California Slaughterhouses

Code: 01802
Violation: 416.13(c), 416.4(a), 416.4(b), 416.13(a)

Citation: After the establishment had conducted the monitoring of the implementation of the SSOP procedure for pre-operational sanitation and prior to the start of operation .While I was conducting routine pre-op SSOP observation procedure (pre-operational hands-on) the organoleptic examination at 0500 hours of the establishment’ sfacilities, equipment and utensils to assess sanitary cond itions. I observed the following noncompliance in the processing room. I observed black hair approx. 2″ long on the white cutting board at the sizing table. [redacted] valle immediately re-cleaned and sanitized the cutting board and it was released by the inspector approx. 0508 hours. I also observed black speck approx.1/16″ in diameter inside the pipe and numerous amount of product residues and what appeared to be black mold. This pipe goes from tumbler tank to the vacuum tumbler. The function of this pipe is sucks up meat from the tumbler tank to the vacuum tumbler. A regulatory control action was taken by applying USDA Reject tag #A9509752 to the pipe and tumbler tank. This pipe was placed inside the tumbler tank, so there is possibility that this tank probably contaminated by the pipe because outside of this pipe numerous amount of product residues and what appeared to be black molds. When I informed [redacted] that this going to be a noncompliance, he said inspector we are not going to use this equipment. I informed him, did it we have this discussion last week, when I perform my pre-up that you will put some kind of identification on the equipments before FSIS inspector start their per-op and you said inspector this would not happen again. I will indentify the equipments that I am not going to use. 9CFR416.13(c) states: “Each official establishment shall monitor daily the implementation of the procedures in the sanitation SOP, 9CFR416.4(a) All food contact surfaces, including food contact surfaces of utensils and equipment, must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product and 9CFR416.4(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.” Direct contact surfaces must be cleaned prior to operations to ensure the food that is produced is safe, wholesome and unadulterated. Residues such as this can provide an excellent growth medium for many micro-organisms, including pathogens [redacted] was notified verbally and physically observer the noncompliance’s. You are herby advised of your right to appeal this decision as delineated by 9CFR306 and/or 9CFR381.35.

Regulation:

416.13(c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.4(a) All food-contact surfaces, including food-contact surfaces of utensils and equipment, must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

416.4(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

416.13(a) Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

Code: 03C02
Violation: 417.5(a)(3), 417.4(a)(2)(ii)

Citation: Today approximately 1625 hours while performing a routine Raw Intact HACCP proced ure for record keeping component.I elected to review record form 09/23/2011, marinated poultry product. While I was reviewing the record I observed [redacted] ) performed daily visual observation at 0915 hours and document the wrong date (09/22/11) instead of 09/23/2011. 9CFR417.5(a)(3) state; “Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan;the calibration of process-monitoring instruments;corrective actions, including all actions taken in response to a deviation;verification procedures and results; product code(s), product name or identity, or slaughter production lot.Each of these records shall include the date the record was made.”How can you support your documentation, when you document the date one day before (09/22/11) the monitor document the monitoring record on 09/23/11? The accurate record keeping of the HACCP Plan is the means by which the safe production of product is produced. If there are questions with the documentation of HACCP record, there may be concerns with the integrity of the product as well. The establishment has not met the requirements of the Federal Poultry Regulation as stated on line six of this NR and the body of this N R. [redacted] physically observed and verbally informed of this noncompliance. You are herby advised of your right to appeal this decision as delineated by 9CFR306 and/or 9CFR381.35.

Regulation:

417.5(a)(3) Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

417.4(a)(2)(ii) Ongoing verification activities. Ongoing verification activities include, but are not limited to: Direct observations of monitoring activities and corrective actions

Code: 01802
Violation: 416.4(a), 416.13(c)

Citation: After the establishment had conducted the monitoring of the implementation of the SSOP proced ure for pre-operational sanitation and prior to the start of operation .While I was conducting routine pre-op SSOP observation procedu re (pre-operational hands-on) the organoleptic examination at 0500 hours of the establishment’ sfacilities, equipment and utensils to assess sanitary conditions. I observed thefollowing noncompliance in the processing Room.

I observed yellowish product residue on food contact surface of two cutting saws, approx. 1″-2″ long from previous day of production. [redacted] was informed and physically observed the noncompliance. Immediate corrective actions were performed by establishment on all affected areas upon notification of my findings. After sanitary measures had been restored, I relinquished the regu latory control action approx.0532 hours. 9CFR416.13(c) states: “Each official establish ment shall monitor daily the implementation of the procedures in the sanitation SOP and 9CFR416.4(a) All food contact surfaces, including food contact surfaces of utensils and equipment, must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.” Direct contact surfaces must be cleaned prior to operations to ensurethe food that is produced is safe, wholesome and unadulterated.

Residues such as this can provide an excellent growth medium for many micro-organisms, including pathogens. [redacted] was notified verbally and physically observer the noncompliance’s . This document serves as written notification that your failure to comply with regulatory requirements could result in additional regulatory or administrative action.You are herby advised of your right to appeal this decision as delineated by 9CFR306 and/or 9CFR381.35.

Regulation:

416.4(a) All food-contact surfaces, including food-contact surfaces of utensils and equipment, must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

416.13(c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

Code: 03C02
Violation: 417.2(a)(1), 417.5(a)(1)

Citation: Today approximately 1648 hours while perform ing routine raw intact HACCP (Raw Not Ground) inspection procedure, review & observation and record keeping component. While I was reviewing the hazard analysis for raw intact HACCP Plan, I observed at the thawing poultry (If needed) step, “potential hazard-Biological-pathogen growth: Salmonella, Chemical-None, Physical-None, Does this significant hazard need to be addressed in HACCP Plan? (Yes/No)-No, Why? (Justification for decision made in previous column)­ Thawing of poultry being monitored as a control point (see written procedures), subsequent CCP in place to control product temperature of the raw materials preventing outgrowth of pathogens.”

When I asked [redacted] to check the surface temperatures of whole birds (chicken) inside the white container, the surface temperatures were 58, 56, 48 degrees F. at 1648 hours and he informed me that this product has not been stage no more than two hours. I asked him for the document and he did not have it at this time, so at this point I couldn’t distinguish when the thawing process started. The thawing procedures for meat and poultry states;’ [redacted] According to 9 CFR 417.5 (a)(1) “The written hazard analysis prescribed in §417.2(a) of this part, including all supporting documentation .” The establishment has not met the requirements of the Federal Meat and Poultry regulation as stated on line six and body of this NR or nor have they met their on SSOP procedures. [redacted] was shown and notified of this noncompliance. This document serves as written notification that your failures to comply with regulatory requirements cited in block six and body of this NR could result in additional regulatory or administrative action. You are herby advised of your right to appeal this decision as delineated by 9CFR306 and/or 9CFR381.35.was notify of this noncompliance.

Regulation:

417.2(a)(1) Hazard analysis. Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.

417.5(a)(1) The establishment shall maintain the following records documenting the establishment’s HACCP plan: The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation

Code: 01C02
Violation: 416.5(b)

Citation: At approximately 1230 hrs while performing a general 06001 inspection of the facility, I observed an employee walking off the loading dock carrying a box but while wearing a white coat. I followed the employee back into the processing room and as he was about to handle product I stopped him and informed him that he needed to change his coat. According to the establishment SSOP’s, employees wearing white coats are only allowed to work and handle product, while employees wearing blue coats are the ones allowed in and out of the processing room and handle non-food items.In the same instance I observed an employee [redacted]) cutting chicken while wearing a blue coat.

[redacted] was informed of the observations and was reminded of the previous 3 verbal warnings regarding this issue as it had been previously observed (the white coat outside the processing room). I explained to [redacted] that this was a non-compliance with 9 CFR 416.5(b) for the use of clean smocks and aprons throughout the process.

[redacted] had a meeting with management instantly and informed them that they need to re-instruct the butchers about the policy as often as needed to prevent a repeat of the instance.

This document serves as written notification that your failure to comply with regulatory requirements could result in additional regulatory or administrative actions.

Regulation:

416.5(b) Clothing. Aprons, frocks, and other outer clothing worn by persons who handle product must be of material that is disposable or readily cleaned. Clean garments must be worn at the start of each working day and garments must be changed during the day as often as necessary to prevent adulteration of product and the creation of insanitary conditions.

Code: 03C02
Violation: 417.2(b)

Citation: At approximately 1354 hours, while performing a routine Raw Intact HACCP task, I observed the following non-compliance:

1) The establishment failed to implement their “Raw, Not Ground Poultry Products (Marinated Poultry Products)” HACCP plan as written, specifically the “Monitoring Frequency” portion.

At approximately 1350 hours, I entered the processing room. I saw [redacted] QC technician, go and grab the clipboard holding the HACCP records. I approached him and asked if he was about to take a temperature to monitor the process controls and he replied “Yes”. I observed [redacted] take the temperature of the marinated chicken breasts with the plant’s thermometer and I observed that it read [redacted] degrees F. I then observed [redacted] write down these results onto the “Product Temperature Log”. After [redacted] put down the clipboard indicating that he was finished, I picked it up and reviewed initialed by [redacted] and got a reading of [redacted] degrees F. [redacted] entry was made at 1:54 p.m. which was two the records. I observed that at 11:30 a.m. the establishment took the last temperature before this one, entry hours and fifty four minutes after the last entry. This [redacted] requirement of the HACCP plan by [redacted].

The above mentioned HACCP plan states, on page 2, in the “Monitoring… Frequency” column : [redacted].

I informed [redacted] , of the non-compliance. [redacted] discussed the events with [redacted] and agreed with me that it appeared [redacted] was late in taking the temperature.

No regulatory control action was necessary because the product in question was still well within the critical limit parameters.

Failure to implement a HACCP plan as written, could result in adulterated product being shipped into commerce.

Regulation:

417.2(b) The HACCP plan. (1) Every establishment shall develop and implement a written HACCP plan covering each product produced by that establishment whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur, based on the hazard analysis conducted in accordance with paragraph (a) of this section, including products in the following processing categories:
(i) Slaughter—all species.
(ii) Raw product—ground.
(iii) Raw product—not ground.
(iv) Thermally processed—commercially sterile.
(v) Not heat treated—shelf stable.
(vi) Heat treated—shelf stable.
(vii) Fully cooked—not shelf stable.
(viii) Heat treated but not fully cooked—not shelf stable.
(ix) Product with secondary inhibitors— not shelf stable.

Code: 03802
Violation: 417.5(a)(3)

Citation: At approximately 1530 hours, while performing a directed Non-intact HACCP Verification task, I observed the following non-compliance:

1) The temperature value was not recorded in the “Prior to Shipping” column of the “Product Temperature Log” for “Ground Chicken” on 06/14/11 at 1:05 p.m.

In the box in the “Temp.” column, where the value should have been written, was written the time of 1:05 p.m. This recording event was initialed by [redacted].

I asked [redacted] if the temperature for the “Prior to Shipping” critical limit had been taken. The initials [redacted] were those of  [redacted] and he was not in the establishment at the time I observed the non-compliance. [redacted] contacted [redacted] via cell phone and asked about the missing temperature. [redacted] then handed the phone to me and [redacted] told me that he did take the temperature and got a reading of 32 degrees F, but that he made an error in not writing the temperature value on the log.

No regulatory control action was taken by me due to [redacted] vouching that he got a temperature reading that met the critical limit [redacted]).

The establishment’s “Raw, Ground Poultry Products” HACCP plan states, on page 1, in the “Critical Limits” column: [redacted]s.”.

Failure to record actual temperatures that are critical limits, could lead to the establishment being unable to determine if adulterated product was produced and shipped into commerce.

Regulation:

417.5(a)(3) Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

Code: 01802
Violation: 416.13(a), 416.4(b), 416.4(a)

Citation: At approximately 0500 hours, while conducting a routine pre-operational SSOP review and observation, I observed thefollowing:

1) Dried blood from the previous day’s production on the white conveyor belt, a food-contact surface, that feeds poultry frames into the mechanical separator.The dried blood was in three different areas of the belt.

2) Bloody water, from the previous day’s production, on the holding pan, a food-contact surface, with three drops in the middle of the pan and bloody water pooled around the drainage hole.

3) Bloody water from the previous day’s production in one corner of a grey lugger, a food-contact su rface, that had dripped into the lugger from the hold ing pan cited in #2 above.

4) Product residue from the previous day’s production adhered to the right front axel for the conveyor belt that feeds prod uct into the mechan ical separator.This was a non food-contact surface.

I notified [redacted] of the noncompliance [redacted] had plant employees immed iately re-clean and sanitize the affected areas. I re-inspected the areas after the re-clean and found them to be acceptable and released the area for production at approximately 0515 hours.

Failure to clean and sanitize food-contact and non food-contact areas as needed could lead to the adulteration of product.

9 CFR 416.4(b), 416.13(a), and 416.4(a) apply.

This document serves as written notification that your failure to comply with regulatory requirement(s) could result in additional regulatory or admin istrative action.

Regulation:

416.13(a) Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

416.4(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

416.4(a) All food-contact surfaces, including food-contact surfaces of utensils and equipment, must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

Code: 01001
Violation: 416.4(d), 416.1, 416.4(b)

Citation: At approximately 1539 hours, while performing a directed sanitation performance standards inspection, I observed the following:

1) A cardboard shipping container (box) of whole chickens packed in ice was about 50 percent uncovered at the top due to the lid having been dislodged, thereby exposing the chickens in the box to the elements.

2) The exposed chickens in the box were being stored directly under a metal rail, a non food-contact surface, which was insanitary.

3) On the underside of the metal rail, directly above the exposed chickens, there were two drops of beaded, brownish colored, water. This water was originating from melting ice in the boxes of chickens stored on the the rails on the second level.

I did not observe any of the water drop onto the chickens, therefore, no regulatory control action was taken .

I showed [redacted] , the exposed chickens, insanitary rail, and water drops. [redacted] removed the box from under the rail, and had a plant employee recond ition the chickens as a precautionary measure.

Failure to protect product during storage, maintain non food-contact surfaces in a sanitary condition, and operate in a manner to prevent insanitary conditions,could lead to the adulteration of product.

Regulation:

416.4(d) Product must be protected from adulteration during processing, handling, storage, loading, and unloading at and during transportation from official establishments.

416.1 Each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated.

416.4(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

NOTICE of SUSPENSION HELD in ABEYANCE:

On May 10, 2013, the Food Safety and Inspection Service (FSIS), Alameda District, notified your establishment of the suspension of the assignment of inspectors and the withholding of the marks of inspection, in accordance with Title 9 Code of Federal Regulations (CFR) Part 500.3 (b). This action was initiated due to your firm’s failure to prevent the inhumane handling and slaughtering of livestock at your establishment and to appropriately handle animals in accordance with Title 9 CFR Part 313.15 (a)(l) and (3). This is in violation of21 U.S.C. 603(b) of the Federal Meat Inspection Act (FMIA) and the Humane Methods of Slaughter Act of 1978 and the regulations promulgated thereunder.

See More Here: PDF

NOTICE of SUSPENSION:

This letter confirms the verbal notification provided to you on May 10, 2013, by the Food Safety Inspection Service (FSIS), Alameda District of the suspension of the assignment of inspectors at your establishment and the withholding of the marks of inspection for your slaughter operations, in accordance with Title 9 Code of Federal Regulations (CFR) Part 500.3 (b). This action was initiated due to your firm’s failure to maintain or implement required controls to prevent the inhumane handling and slaughtering of livestock at your establishment and appropriately handle animals in accordance with Title 9 CFR 313.15 (a)(1) and 313.15(a)(3). This is in violation of 21 U.S.C. 603 (b) of the Federal Meat Inspection Act, and the Humane Methods of Slaughter Act of 1978, and the regulations promulgated thereunder.

See More Here: PDF

Code: 01001
Violation: 416.2(d)

Citation: At approximately 1045 hours, while performing the PHIS SPS Verification task for review and observation verification activities throughout the plant, the following sanitation performance standard noncompliance was found. I observed an insanitary condition inside the raw product freezer that frozen icicles (frozen condensation) build up in front of cooling unit number one toward the entrance door on the overhead structure. Although I did not observe any dripping of the condensate, this constitutes an insanitary condition and a potential for product contamination. Since no contamination of product was observed at the time no product was retained .The establishment has not met the req uirementsof 9 CFR 416.2(d) which states, “Ventilation adequate to control odors, vapors, and condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions must be provided.” I showed this non compliance to production [redacted]. Later this issue of noncompliance was discussed with [redacted]. There was no NR with the similar cause in the filter value that could be linked with this NR This document serves as written notification that your failure to comply with regulatory requirement(s) could result in additional regulatory or administrative action

Regulation:

416.2(d) Ventilation. Ventilation adequate to control odors, vapors, and condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions must be provided.

Code: 01802
Violation: 416.13(c), 416.13(a)

Citation: While performing preoperationa l Sanitation SOP verification task for review and observa tion at approximately 0455 hours after the plant’s pre -operational inspection and prior to the start of operations the following noncompliance was found in raw processing area.I observed the treif slicer was insanitary cond ition in raw processing area. During hands-on inspection inspection I found residue material, which was from previous day production on the treif slicer in raw processing area . I showed this non compliance to product [redacted] Corrective action was taken immediately. At 0500 hours re-inspection performed on the treif slicer was acceptable [redacted] was informed that a noncompliance will be issued for the insanitary conditions which could lead to the adulteration of product. Based on my observations and review of records; the establishment is not performing the monitoring procedures as stipulated in their SSOP manual. Establishment failure to compliance with USDA regulatory requirements 9CFR 416.13(a) and (c). “9CFR 416.13 (a) each official establishment shall cond uct the preoperational procedures in the Sanitation SOPs before the start of operations.9CFR 416.13 (c) Each officials shall monitor daily the implementation of the procedures in the Sanitation SOPs”.It is a regulatory requirement that establishments adequately implement the procedures specified in their SSOP program. In this case the establishment hasfailed to detect, through its pre-operational sanitation inspection, the residue material on the product contact surface described above. This document serves as written notification that your failure to comply with regulatory requirement(s) could result in additional regulatory or administrative action

Regulation:

416.13(c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

416.13(a) Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

Code: 03G02
Violation: 417.3(c)

Citation: At approximately 0940 hours while performing Fully Cooked – Not Shelf Stable HACCP task for record keeping verification activities I noted that there was a deviation from critical limit in the Re -Packaging HACCP monitoring log. The monitoring activity had been performed for the day of 09/29/2011 product was Roast Beef temperature was document 43.1degree Fat 0931 hours. According establishment HACCP Plan for Re – Packaging Fully Cooked -Not Shelf Stable product, ‘[redacted] “. In addition the record review and pre shipment had been documented as performed on 09/30/2011 and product temperature at shipping [redacted] degree F at 0720 hours with no deviation or corrective action. There was no record available to review for corrective action. [redacted] informed IIC that correction action was taken but he forgot to document. The establishment did not comply with Re -Packing Fully Cooked -Not Shelf Stable HACCP which states [redacted] ” I informed [redacted] that establishment did not meet the USDA regulatory requirement of 9CFR 417.3(c). The establishment did not comply for Fully Cooked – Not Shelf Stable HACCP corrective action requirement of 9CFR 417.3(c), which states, “All corrective actions taken in accordance with this section shall be documented in records that are subject to verification in accordance with §417.4(a)(2)(iii) and the recordkeeping requirements of §417.5 of this part”. There was no NR with the similar cause in the filter value that could be linked with this NR. This document serves as written notification that your failure to comply with regulatory requirement could result in additional regulatory or administrative action.

Regulation:

417.3(c) All corrective actions taken in accordance with this section shall be documented in records that are subject to verification in accordance with § 417.4(a)(2)(iii) and the recordkeeping requirements of § 417.5 of this part.

Code: 01802
Violation: 416.13(a), 416.13(c)

Citation: While performing preoperational Sanitation SOP verification task for review and observation at approximately 0455 hours after the plant’s pre-operational inspection and prior to the start of operations the following noncompliance was found in raw processing area. I observed two scales were insanitary condition in raw processing area.Scale number one and two has fat and black residues under the scale bases. In addition bottom of scale number two observed rust like oxidation color and flanking paint. [redacted] was informed that a noncompliance will be issued for the insanitary conditions which could lead to the adulteration of product. Corrective action was taken immediately Scale number two was removed from the production by [redacted]. At 0510 hours re-inspection performed on the scale number one was acceptable. Based on my observations and review of records; the establishment is not performing the monitoring procedures as stipulated in their SSOP manual. Establishment failure to compliance with USDA regulatory requirements 9CFR 416.13(a) and (c). “9CFR 416.13 (a) each official establishment shall cond uct the preoperational procedures in the Sanitation SOPs before the start of operations. 9CFR 416.13 (c) Each officials shall monitor daily the implementation of the procedures in the Sanitation SOPs”. It is a regulatory requirement that establishments adequately implement the procedures specified in their SSOP program. In this case the establishment has failed to detect, through its pre-operat ional sanitation inspection, the fat and black residue on the product contact surface described above.This document serves as written notification that your failu re to comply with regulatory requirement( s) could result in additional regulatory or admin istrative action.

Regulation:

416.13(a) Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

416.13(c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

Code: 01001
Violation: 416.2(b)(2), 416.4(b)

Citation: At approximately 0455 hours while conducting the pre- op SSOP Review and Observation task and SPS verification. I observed what appeared to be a moist black moldy substance (approximately 6 inch in length and 2 inch wide) underneath the bottom of the glass window on the freezer door (freezer number six). This door leads from the RTE packaging room into the freezer number six. I showed this to [redacted]. The establishment has failed to comply with the regulatory requirements of 9CFR; 416.2 (b) (2) and 9CFR; 416.4 (b). I informed [redacted] that establishment did not meet the USDA regulatory requirements9CFR; 416.2 (b)(2) Which states, “Walls, floors, and ceilings within establishments must be built of durable materials impervious to moisture and be cleaned and sanitized as necessary to prevent adulteration of product or the creation of insanitary conditions.” and 9CFR;416.4 (b) which states, “Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.” There was no NR with the similar cause in the filter value that could be linked with this NR. This document serves as written notification that your failure to comply with regulatory requirement could result in additional regu latory or administrative action.

Regulation:

416.2(b)(2) Walls, floors, and ceilings within establishments must be built of durable materials impervious to moisture and be cleaned and sanitized as necessary to prevent adulteration of product or the creation of insanitary conditions.

416.4(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

Code: 01001
Violation: 416.2(a), 416.1, 416.2(b)(3)

Citation: This morning at approximately 1100 while collecting an RTE sample in the establishments packaging/slicing room I observed a flying insect (turned out to be as I suspected, a common house fly) which landed on a product contact surface of the chopper. The chopper had been used earlier in the morning but would not be used the remainder of the day. I informed [redacted] of the flying insect, who then promptly dispatched the flying insect and removing its remains.Since I did not observe the insect land onto product or product contact equipment currently being used at that time, I did not initiate official control action. As required by 9CFR 416.1, “Each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated.” Also as required by 9CFR 416.2(a), an establishment must employ an effective pest control program to prevent entrance of such vermin. [redacted] was advised of this incident later in the day.

Regulation:

416.2(a) Grounds and pest control. The grounds about an establishment must be maintained to prevent conditions that could lead to insanitary conditions, adulteration of product, or interfere with inspection by FSIS program employees. Establishments must have in place a pest management program to prevent the harborage and breeding of pests on the grounds and within establishment facilities. Pest control substances used must be safe and effective under the conditions of use and not be applied or stored in a manner that will result in the adulteration of product or the creation of insanitary conditions.

416.1 Each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated.

416.2(b)(3) Walls, floors, ceilings, doors, windows, and other outside openings must be constructed and maintained to prevent the entrance of vermin, such as flies, rats, and mice.

Code: 03G02
Violation: 417.5(b)

Citation: At approximately 1000 hours while performing Fully Cooked -Not Shelf Stable HACCP task for record keeping verification activities I noted that there was no time recorded in the Re -Packaging HACCP monitoring log. The monitoring activity had been performed for the day of 08/31/2011.The establishment did not meet the USDA regulatory requirement of 9CFR 417.S(b). I informed [redacted] that establishment did not comply for Fully Cooked -Not Shelf Stable HACCP record keeping requirement of 9CFR 417.S(b) which States” Each entry on record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee”. There was no N R with the similar cause in the filter value that could be linked with th is NR.This document serves as written notification that your failure to comply with regulatory requirement could result in additional regulatory or administrative action.

Regulation:

417.5(b) Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.

Code: 03H02
Violation: 417.5(a)(1)

Citation: 1. During the food safety assessment, [redacted] reviewed the validation studies for the cooking instructions of 2011. The establishment did not provide the documentation of the validation of different ways to cook the product. For example, for the validation of the cooking instructions for the 1oz. chicken/pork potsticker conducted 02/09/2011, the establishment documented the validation of pan frying the product. However, the product label also contains “deep frying.” The establishment did not document validation studies for the deep frying of the 1oz. potsticker product. In another example, the establishment conducted a validation study of the cooking instructions for the pork/chicken battered nuggets. The establishment documented validation of the baking instructions. The product label also includes deep frying instructions. The establishment did not document a validation for the deep frying instructions. The orange chicken product label (packaging box label) also contains skillet instructions, for which the establishment does not have documented validation. Also, the validation documentation does not make it clear what the documented temperatures pertain to. For example, the pork bun/chicken bun product was documented to have a product temperature of 170 Fon 02/10/2011. The packaging box label for the Chinese steamed pork buns indicates that the product can be cooked by steaming or microwaving.It is not clear whether the documented temperature of [redacted] F applies to the steaming or the microwaving. In addition, the validation documentation documents longer cooking timeframes than the timeframes on the product label. For example, the cashew egg roll product label indicates that the egg rolls should be baked for 6 minutes, turned, then baked an additional 6 minutes, which is a total of a 12-minute baking time. However, the establishment documented a validated baking time a minutes (from 8:25am to 8:40am) on 02/20/2011. The validated baking instructions have a longer timeframe than what is on the product label. In addition, certain instructions on product label are not documented in the validation. For example, for the chicken won ton product with validation documented 05/18/2011, the product label indicates that the fryer should be preheated to 350F. However, the validation documentation does not indicate whether the fryer was preheated to 350F during the validation study. In another example, the product label for the 3.5 oz.chicken/ pork battered egg roll product indicates that the product should be thawed for 5 minutes prior to baking or frying. The validation documentation does not indicate whether the product was thawed for [redacted] minutes prior to baking or frying. Based on EIAO findings, the establishment’s validation studies are incomplete and therefore insufficient to support the current cooking instructions on products labels for the products that fall under the Heat-Treated, Not Fully Cooked, Not Shelf-Stable process category. The establishment is unable to support its hazard analysis decisions that there are no biological hazard s reasonably likely to occur with respect to its cooking instructions. This is a noncompliance with ntle 9 CFR 417.5(a)(1).

Regulation:

417.5(a)(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation

Code: 03H02
Violation: 417.5(a)(1), 417.5(a)(2), 417.5(a)(3)

Citation: 1. In the hazard analysis at the “Cooling” step where Cooling CCP B-1is established, the establishment identifies ‘ [redacted]. However, the establishment does not identify specific pathogens,such as Salmonella, Campylobacter, or Trichinae.Salmonella has historically occurred in meat and poultry, Campylobacter has historically occurred in poultry, and Trichinae has historically occurred in pork. The establishment did not provide any support for not addressing these pathogens. This is a noncompliance with Title 9 CFR 417.5(a)(1). In addition, the hazard analysis references [redacted] “at several process steps as justification for the decision that no biological hazards are associated with those steps.The establishment has a program entitled “Storing WIP products in warehouse” which states, [redacted] .” The program does not specify the targeted product temperature. On 2/21/2011, [redacted] indicated that the establishment does not monitor the product temperature. He indicated that the establishment main ly monitors the freezer and cooler temperatures via the establishment’s computer system connected to the freezers and coolers.The establishment’s computer system monitors the cooler and freezer temperatures every [redacted] minutes, reports the temperatures to the computer, and alarms if there is any problem. Therefore, the establishment is not monitoring the product temperature as described in the “Storing WIP products in warehouse” program and as indicated in the hazard analysis. This is a noncompliance with Title 9 CFR 417.5(a)(1) for failure to provide adequate supporting documentation for the hazard analysis decision that no biological hazards are associated with those process steps. Additionally, the establishment is maintaining validation studies from 2006 for the Heat-Treated, Not Fully Cooked, Not Shelf-Stable HACCP plan to demonstrate that the HACCP plan is functioning as intended. The establishment conducted these studies on the following products:pork mini spring roll, chicken egg roll, pork potsticker, chicken potsticker,and pork egg roll.However, the establishment also produces battered chicken/ch icken nuggets, buns containing meat/poultry filling, and empanadas under the Heat-Treated, Not Fully Cooked, Not Shelf-Stable HACCP plan. On 12/21/2011 and on 12/22/2011, [redacted] asked [redacted] whether the establishment conducted validation studies for these products. He indicated that the establishment does not have any validation documentation for these products. He indicated that, based on the establishment’ s HACCP data on file (at least three years), [redacted] However, the establishment is not maintaining any decision-mak ing documents that explain this.This is a noncompliance with Title 9 CFR 417.5(a)(2) . Also, in reviewing the [redacted] CCP-B1records, [redacted] determined that the establishment is not meeting its frequency for once every hour [redacted] minutes in accordance with the Heat-Treated, Not Fully Cooked, Not Shelf-Stable HACCP plan. [redacted] reviewed records dated through 10/04/2011 through 12/05/2011. The monitoring procedures in the HACCP plan are [redacted] .”For the following HACCP records, the establishment did not meet the frequency for every hour [redacted] minutes). (The first time listed below is the documented time of monitoring at the start of cooling. The second time listed below is the documented time of monitoring at the end of cooling.) This is a noncompliance with Title 9 CFR 417.2(b)(1) and 417.5(a)(3) . 1. 12/05/2011, pork egg roll, 8:40am then 10:15a m 2. 12/01/2011, pork bun, 1:06pm then 3:06pm 3. 11/29/2011, battered chicken egg 10/24/2011, pork egg roll, 12:30pm then 2:10pm 7. 10/14/2011, pork potstickers, 6:24pm then 7:SSpm 8. 10/06/2011, pork potstickers, 3:20pm then 5:l0pm

Regulation:

417.5(a)(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation

417.5(a)(2) The written HACCP plan, including decisionmaking documents associated with the selection and development of CCP’s and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

417.5(a)(3) Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

Code: 03802
Violation: 417.2(c)(6), 417.3(a)(3), 417.3(a)(4), 417.3(a)(2), 417.2(c)(4), 417.5(a)(3), 417.3(a)( 1), 417.5(a)(2)

Citation: In reviewing the [redacted] CCP records (” [redacted] ” forms) dated 10/6/2011 through 12/12/2011, [redacted] determined that the establishment is not meeting the [redacted] for monitoring .EIAO found in the records that, almost daily, the establishment is not meeting this [redacted] frequency. Also, the establishment is not meeting the frequency for direct observation, which is [redacted] In the following records, the establishment did not document direct observations. These are noncompliances with Title 9 CFR 417.2(b)(1) and 417.5(a)(3). • 11/10/11 • 11/09/11 • 11/8/11 • 11/3/11 • 11/2/11 • 12/1/11 In addition, the [redacted] CCP [redacted] ) records have a section that says, “Doc. review.” When [redacted] asked for clarification on whether the establishment is documenting record review verification of the HACCP plan or pre-shipment review in this “Doc. review” section, on 12/21/2011 [redacted] indicated that the “doc.review” is for both record review and pre-shipment review. [redacted] informed him that the establishment cannot use this ‘doc.review” to meet the regulatory requirements for both record review verification and pre-shipment review. This is a noncompliance with Title 9 CFR 417.5(a)(3) and 417.5(c). Also, the establishment is not documenting results for the observations obtained during monitoring procedures, direct observations, and record review for the [redacted] CCP in the [redacted] HACCP Records (” [redacted] ” forms) Additionally, the establishment is not always documenting the lot numbers or product identity in the [redacted] CCP HACCP records. These are noncompliances with Title 9 CFR 417.2(c)(6) and 417.5(a)(3). Furthermore, the establishment is not maintaining any scientific, technical, or regulatory supporting documentation for the [redacted] CCP HACCP plan, including supporting documentation for the critical limit. This is a noncompliance with Title 9 CFR 417.5(a)(2). Additionally, the establishment’s [redacted] CCP HACCP plan specifies the following as its critical limit: [redacted] ” Title 9 CFR 417.2(c)(3) states that the HACCP plan shall ‘list the critical limits that must be met at each of the critical control points. Critical limits shall, at a minimum, be designed to ensure that applicable targets or performance standards established by FSIS, and any other requirement set forth in this chapter pertaining to the specific process or product, are met.” The establishment’s listed critical limit for the [redacted] CCP does not specify an “applicable target”; the critical limit simply specifies the seeded samples that the estbalishment will be using to monitor the CCP. This is a noncompliance with Title 9 CFR 417.2(c)(3). Also, the corrective action procedures in the HACCP plan for the Metal Detection CCP states the following: ” [redacted] .” This HACCP plan does not assign a person responsible for conducting corrective actions. This is a noncompliance with Title 9 CFR 417.3(a). Moreover, in reviewing and observing the [redacted] CCP, [redacted] determined that the establishment is no longer able to support the monitoring procedures as written in the HACCP plan. On 12/14/2011, [redacted] observed that the establishment is able to accurately detect the seeded samples when the seeded sample cards are taped onto the product bags that pass through the metal detector. If the establishment does not tape product onto bags, [redacted] observed that the metal detector’s rejecting mechanism does not work effectively to remove the product off of the line as intended. On 12/14/2011, [redacted] instructed plant employees to tape seeded samples onto product bags from now on beginning 12/14/2011. However, the establishment did not revise its written monitoring procedures in its Metal Detection CCP HACCP plan. The establishment is no longer able to support the current written monitoring procedures for the Metal Detection CCP. This is a noncompliance with ntle 9 CFR 417.2(c)(4) and 417.5(a)(2).

Regulation:

417.2(c)(6) Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.

417.3(a)(3) Measures to prevent recurrence are established; and

417.3(a)(4) No product that is injurious to health or otherwise adulterated as a result of the deviation enters commerce.

417.3(a)(2) The CCP will be under control after the corrective action is taken

417.2(c)(4) List the procedures, and the frequency with which those procedures will be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits

417.5(a)(3) Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

417.3(a)(1) The cause of the deviation is identified and eliminated

417.5(a)(2) The written HACCP plan, including decisionmaking documents associated with the selection and development of CCP’s and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

Code: 03802
Violation: 417.5(a)(1)

Citation: In the hazard analysis where CCP B-1and CCP B-2 are established, the establishment identifies “growth of pathogens”as a biological hazard reasonably likely to occur.However, the establishment does not identify specific pathogens, such as Salmonella, Campylobacter, or Trichinae. Salmonella has historically occurred in meat and poultry, Campylobacter has h istorically occurred in poultry, and Trichinae has historically occurred in pork. The establishment d id not provide any support for not addressing these pathogen s.This is a noncompliance with Title 9 CFR 417.5(a)(1). In addition, the hazard analysis references “temperature control of all WIP [work-in-process] items” at several process steps as justification for the decision that no biological hazards are associated with those steps.The establishment has a program entitled “Storing WIP products in warehouse” which states, [redacted] ” The program does not specify the targeted product temperature. On 12/21/2011 [redacted] indicated that the establishment does not monitor the product temperature. He indicated that the establishment main ly monitors the freezer and cooler temperatures via the establishment’ s computer system connected to the freezers and coolers.The establishment’s computer system monitors the cooler and freezer temperatures every [redacted] minutes, reports the temperatures to the computer, and alarms if there is any problem. Therefore, the establishment is not monitoring the product temperature as described in the “Storing WIP products in warehouse” program and as indicated in the hazard analysis. This is a noncompliance with Title 9 CFR 417.S(a)(l) for failure to provide adequate supporting documentation for the hazard analysis decision that no biological hazards are associated with those process steps.

Regulation:

417.5(a)(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation;

Code: 03802
Violation: 417.5(a)(2)

Citation: The establishment is maintaining validation studies from 2006 for the Heat-Treated, Not Fully Cooked, Not Shelf-Stable HACCP plan to demonstrate that the HACCP plan is functioning as intended.The establishment conducted these studies on the following Heat-Treated, Not Fully Cooked, Not Shelf-Stable products:pork mini spring roll, chicken egg roll, pork potsticker, chicken potsticker,and pork egg roll. [redacted] informed [redacted] that the establishment is utilizing the validation data for the Heat-Treated, Not Fully Cooked, Not Shelf-Stable HACCP plan to support its Raw Ground HACCP plan (which includes the mini skewer (Raw, Not Ground product)). Based on the cooling speed shown in the heat-treated HACCP plan validation data [redacted] indicated that there should be no problem in meeting the cooling critical limits for the Raw, Ground/Raw, Not Ground HACCP plan [redacted] also indicated, that based on the three years of HACCP records that the establishment has on file, the establishment has not had any problems implementing the Raw, Ground/Raw, Not Ground HACCP plan and that there have been no deviations from the critical limit. However, the establishment is not maintaining any decision-making documents to describe this thought process. In addition, the establishment did not provide any supporting documentation to demonstrate that the validation data for the Heat-Treated, Not Fully Cooked, Not Shelf-Stable process can be applied to the Raw, Ground/Raw, Not Ground process.This is a noncompliance with Title 9 CFR 417.S(a)(2).

Regulation:

417.5(a)(2) The written HACCP plan, including decisionmaking documents associated with the selection and development of CCP’s and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

Code: 01001
Violation: 416.2(b)(2), 416.2(d), 416.2(g)(1)

Citation: On 12/07/2011, during the food safety assessment (FSA), [redacted] observed black unidentified foreign material that appeared to be mold above the spiral freezer. [redacted] did not observe any product contamination [redacted] informed [redacted] of this observation . This finding is a noncompliance with ntle 9 CFR 416.2(b)(2) and 416.2(d). Also, during the food safety assessment (FSA) [redacted] reviewed the establishment’s documentation certifying water potability. The establishment’ s contracted laboratory [redacted] conducted testing of its water and ice. [redacted] indicated that the establishment uses city water and uses that water to make the establishment’s ice [redacted] indicated that the establishment tests the water and ice usually at the beginning of each year. The establishment is maintaining a report dated 01/23/2011 by [redacted] indicating that both the water and ice samples (analysis date 01/20/2011) were [redacted]. However, th is documentation is insufficient to meet the regulatory requirement. Title 9 CFR 416.2(g)(1) states, “If an establishment uses a municipal water supply, it must make available to FSIS, upon request, a water report, issued under the authority of the State or local health agency, certifying or attesting to the potability of the water supply.” This is a noncompliance with this regulation.

Regulation:

416.2(b)(2) Walls, floors, and ceilings within establishments must be built of durable materials impervious to moisture and be cleaned and sanitized as necessary to prevent adulteration of product or the creation of insanitary conditions.

416.2(d) Ventilation. Ventilation adequate to control odors, vapors, and condensation to the extent necessary to prevent adulteration of product and the creation of insanitary conditions must be provided.

416.2(g)(1) Water supply and water, ice, and solution reuse. A supply of running water that complies with the National Primary Drinking Water regulations (40 CFR part 141), at a suitable temperature and under pressure as needed, must be provided in all areas where required (for processing product, for cleaning rooms and equipment, utensils, and packaging materials, for employee sanitary facilities, etc.). If an establishment uses a municipal water supply, it must make available to FSIS, upon request, a water report, issued under the authority of the State or local health agency, certifying or attesting to the potability of the water supply. If an establishment uses a private well for its water supply, it must make available to FSIS, upon request, documentation certifying the potability of the water supply that has been renewed at least semi-annually.

Code: 01802
Violation: 416.13(a)

Citation: During the food safety assessment (FSA), on 12/07/2011, at approx. 0600 hours, [redacted] observed the [redacted] conduct the establishment’s pre-operational sanitation procedures. (The establishment usually conducts pre-operational sanitation procedures at midnight, and FSIS in-plant inspection usually conducts pre-operational sanitation inspection at 0600 hours the following morning. [redacted] indicated that he will conduct pre-operational sanitation procedures on 12/07/2011at 0600 hours for FSIS observation during the FSA.) During [redacted] pre-operat ional sanitation inspection, [redacted] observed that he conducted the pre-operational sanitation procedures as written by inspecting the food contact surfaces to be used. However, once operations started, [redacted] observed employees use several food contact surfaces that [redacted] did not monitor during his pre-operational sanitation procedures. These food contact surfaces that were not inspected included the following:bowls, metal trays, scissors, scales, plastic chips (used by employees to track number of eggrolls wrapped), colander for eggroll mix, white gondola for eggroll mix, buckets for corn starch, ladle for com starch, more white gondolas, metal trays for racks of heat-treated, not shelf-stable, not fully cooked product, large chisel-looking tool, scoops, bucket and bowl used for transferring vegetable oil into the small fryer, machete with blue hand le used for cutting dough, long metal spatu la for batter, trays for egg rolls, and bucket and scoops used for holding and transferring water. [redacted] observed that these food contact surfaces were of sanitary condition and did not observe any product contaminat ion or adulteration. The establishment’s pre-operational SSOP states, [redacted] “The establishment did not implement the pre-operational SSOP as written in the SSOP program .This is a noncompliance with ntle 9 CFR 416.13(a).

Regulation:

416.13(a) Each official establishment shall conduct the pre-operational procedures in the Sanitation SOP’s before the start of operations.

Code: 04804
Violation: 317.1

Citation: At 0830 hours while cond ucting review and observation activities associated with a sched uled operational sanitation task regulatory noncompliance was identified. Three five gallon buckets,white in color, and one bulk dry ingredient storage container, white in color / on wheels, displayed no form of identifying what was contained inside. These containerswere located in the production kitchen near the bowl chopper. The containers/ ingredients were “in-use”. This regulatory issue was brought to the attention of plant management and they immediately labeled the containers with a permanent marker. One of the buckets contained vegetable oil (soybean ) the other two buckets contained granulated / chopped garlic and the bulk container contained potato starch. Due to the regulatory issue being immediately corrected no regulatory control action was needed.

Regulation:

317.1 (a) When, in an official establishment, any inspected and passed product is placed in any receptacle or covering constituting an immediate container, there shall be affixed to such container a label as described in § 317.2 except that the following do not have to bear such a label.

Code: 01802
Violation: 416.4(b), 416.4(a), 416.13(c)

Citation: Today on 11/23/11at approximately 06:05 hours after the plant’s pre-operational inspection and prior to the start of operations the following noncompliance was found [redacted] was conducting a hands-on inspection and during the inspection [redacted] was accompanied by two plant employees who were shown the insanitary conditions within the establishment .In the Egg Roll Production Room at the Fryer/Batter System I found in the Flour Tumbler a white powder residue within the tumbler. At, the entrance conveyor belt for the Flour Tumbler there was dried on food particles including a white powder residue.The Batter Conveyor Belt contained dried on food particles within various locations of the belt. On, the Transfer Conveyor Belts there was dried on food particles within the belt webbing. All of the above mentioned food particles ranged in size from 1/4 inch to 1/2, inch in size and width. And, all of the above mentioned items are direct Food Contact Surfaces. In the Packaging Room I found all three of the establishments Metal Detectors (non-food contact) with food and fat particles through out the machines. Also, there was a Packaging Unit which contained foreign material, carton fibers, and a black greasy substance within the divider trays of the machine.In the divider trays section is where packaged product is placed to be inserted into the final consumer cartons. All of these insan itary items were shown to plant (pre-op) personnel and they were notified that a noncompliance will be issued for the insanitary conditions which were found during today’s inspection. Upon further investigation I reviewed the establishment’s SSOP Pre-Op paperwork and their inspection was done on 11-22-11(23:40 hours) and the above mentioned items were inspected and found to be acceptable. And, there was no re-inspection of this equipment prior to inspection personne l inspection. Thisdescribes an insanitary condition which could lead to the adulteration of product. The establishment’s monitoring failed to detect the insanitary conditions which were found during today’s inspection personnel inspection. During today’s inspection [redacted] observed direct contamination of found processing equipment and product contact surfaces which were not found during the plant’s pre-op operational inspection. No Regulatory Control action was taken as these items were re-cleaned and re-inspected prior to operations. This is noncompliance with 9 CFR 416.13 (c) and 416.4 (a) (b). FSIS Issued NR # HBM2615102805N/1 dated 10/5/11 for similar noncompliance of insanitary conditions which were found during pre-op inspection at the establishment .And, the plant’s previous preventative measurers were ineffective in eliminating this noncompliance trend.This document serves as written notification that your failure to comply with regulatory requirements could result in additional regulatory or administrative action.

Regulation:

416.4(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

416.4(a) All food-contact surfaces, including food-contact surfaces of utensils and equipment, must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

416.13(c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

Code: 03H02
Violation: 417.2(a)(1), 417.2(a)(2)

Citation: At 2200 hours while observing the production process of battering and applying a heat treatment (frying) to the eggrolls I noted the following activity. A production employee was stripping the filling from defective or mis-shaped eggrolls that completed the heat treatment step (frying). I inquired about this activity and it was explained that the filling is salvaged from the defective eggrolls and then re-used at a later date to manufacture eggrolls.Wanting to know more about the re-use of the eggroll filling I directed my attention to the establishment HACCP plan covering the production of heat treated-not fully cooked-not shelf stable products dated October 12, 2011. Upon reviewing the HACCP plan, flow diagram & hazard analysis, covering the production of eggrolls I found no mention of the salvage & re-use of thefilling after having completed the heat treatment step.The flow diagram contains a statement declaring “NO REWORK” .

Regulation:

417.2(a)(1) Hazard analysis. Every official establishment shall conduct, or have conducted for it, a hazard analysis to determine the food safety hazards reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control those hazards. The hazard analysis shall include food safety hazards that can occur before, during, and after entry into the establishment. A food safety hazard that is reasonably likely to occur is one for which a prudent establishment would establish controls because it historically has occurred, or because there is a reasonable possibility that it will occur in the particular type of product being processed, in the absence of those controls.

417.2(a)(2) A flow chart describing the steps of each process and product flow in the establishment shall be prepared, and the intended use or consumers of the finished product shall be identified.

Code: 01001
Violation: 416.4(b), 416.1

Citation: While I was performing the review and observation component of pre-operational sanitation inspection at 0600 hours, operations were not in progress and at 0620 hours I observed in cooler #6 12 bluish-colored fan covers for the 2 refrigera tion units on wall of said cooler #6 with accumulations of rust (easily dislodged with my finger) and extraneous matter (also easily dislodged with my finger) on outer surfaces of all fan covers. The fan covers are made up of 22 equally spaced concentric circles with varying amounts of rust and other matter which makes some of the surface areas of the covers reddish-orange in color. The air flow from the refrigeration units is out away from the refrigeration un its into the open cooler. The air flow is not forceful but could dislodge the rust particles or other matter from the fan covers if the covers are not cleaned regularly. All products placed below and around the refrigeration un its and fan covers are covered with clear plastic wrap. I did not observe any product contamination . I d id observe a cart with several trays of exposed product about 25 feet from the refrigeration units and fan covers. I informed [redacted] of the noncompliance. No regulatory control action taken at this time.

Regulation:

416.4(b) Non-food-contact surfaces of facilities, equipment, and utensils used in the operation of the establishment must be cleaned and sanitized as frequently as necessary to prevent the creation of insanitary conditions and the adulteration of product.

416.1 Each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated.

Code: 01802
Violation: 416.14, 416.13(c)

Citation: Today on 10/5/11 at approximately 06:25 hours prior to the start of operations the following noncompliance was found. I was in the production area and I found the Fryer/Batter System which food particles which was from the previous day’s production. In the flour tumbler there was a white powder residue within the tumbler, the batter conveyor belt contained dried on food particles, and several of the transfer conveyor belts contained food particles within various locations within this entire system. During my inspection a plant employee was shown these items and immediate corrective action was taken.Upon further investiagtion I reviewed the establishment ‘s SSOP Pre-Op paperwork and this system was inspected and passed on 10/4/11 and there was no re-inspection of this equipment prior to inspection personnel inspection . This describes an insanitary condition which could lead to adulteration of product since, these noncompliances were not found by plant personnel prior to the start of operations.The establishment was producing an amenable Heat Treated Not Fully Cooked Not Shelf Stable product. I notified [redacted] of the insanitary conditions which were found during today’s inspection and also notified h im that a noncompliance will be issued.

Regulation:

416.14 Each official establishment shall routinely evaluate the effectiveness of the Sanitation SOP’s and the procedures therein in preventing direct contamination or adulteration of product(s) and shall revise both as necessary to keep them effective and current with respect to changes in facilities, equipment, utensils, operations, or personnel.

416.13(c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

Code: 03H02
Violation: 417.5(a)(3), 417.5(b)

Citation: On August 4,2011at approximately 18:00 hours , while performing ISP Task code 03H02 , record keeping component, I noticed a non-compliance in the Haccp monitoring record for the cooking and cooling ccp’s, two entries were not made on time for 13:30 hrs, no initials at that specific entry and missing or illegible entries made by 1st shift QA ,these entries were unclear and i was unable to read the results entered, I immediately contacted [redacted] and I alerted him of this non-copliance with 9CFR 417.5(a)(3). All records must be maitained on daily basis and kept organized to document the monitoring of the product ccp’s.failure to comply with the regulatory requirement could result in additional admin istrative or regulatory action.

Regulation:

417.5(a)(3) Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

417.5(b) Each entry on a record maintained under the HACCP plan shall be made at the time the specific event occurs and include the date and time recorded, and shall be signed or initialed by the establishment employee making the entry.

Code: 03H02
Violation: 417.2(c)(6), 417.3(b)(1), 417.3(b)(2), 417.5(a)(l), 417.5(a)(3)

Citation: Today, while preforming a routine HACCP verification in establishment #11057 M-Harvest Foods, INC, I found a utility bin of unlabeled turnovers. These were individually cello wrapped and frozen. I found [redacted], [redacted] and requested further information. [redacted] stated that the items in the bin were “Experimental Samples” [redacted] stated there was 164 beef and chicken empanadas were represented when actually there was 300+. I requested the production records of this product and [redacted] stated there were none for the production of this sample. I reminded [redacted] that on January 5,2011,we had a simular issue with samples. It was explained then that samples fall under HACCP, SSOP and CCP’s needed to be recorded. Experimental product is under the control of the establishement. This utility bin also did not have any notation of type of product, allergen, and speicies. I reviewed the Product information sheet, the flow chart as well as the reassessment page of the HACCP. Beef empanadas are not listed as a product. There was no notation on reassessment of the plan since August 2010. I notified [redacted] who directed me to retain the product. Upon further assessment of the sample product, 24 weiner dogs were also presented by [redacted] as sample product produced without HACCP recordkeeping. These were added along with another rack of 69 more beef and chicken empanadas. I applied USDA tag Number 821588268 to the utility bin.

Regulation:

417.2(c)(6) Provide for a recordkeeping system that documents the monitoring of the critical control points. The records shall contain the actual values and observations obtained during monitoring.

417.3(b)(1) Segregate and hold the affected product, at least until the requirements of paragraphs (b)(2) and (b)(3) of this section are met;

417.3(b)(2) Perform a review to determine the acceptability of the affected product for distribution;

417.5(a)(1) The written hazard analysis prescribed in § 417.2(a) of this part, including all supporting documentation

417.5(a)(3) Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

Code: 03G02
Violation: 417.5(a)(3), 417.5(a)(2)

Citation: Today at approx.0600 hours while performing a HACCP procedure for fully cooked product in the quality control office using the record review component the following noncompliance was observed: The establishments HACCP plan group A states for the (Monitoring Procedure and Frequency) that, [redacted]. Review of the record titled. “Temperature during Process Log (CCP-3)” dated 12/04/11 for second shift indicated that at 17:33 or possibly 17:55, (documentation not legible) the monitor with the initials [redacted] took the temperature of the product “Chopped Ital ian Salad”. However the next monitoring event occurred at 21:00 hours as indicated by the monitor with the initials [redacted] for the product “Caesar Salad w/Chicken”, failing to meet the monitoring frequency of every 2 hours as required by their written HACCP plan. [redacted] was informed of and shown this noncompliance and of the establishments failure to meet the Federal Meat Regulations cited on line six of this noncompliance record and also their written HACCP plan.

Regulation:

417.5(a)(3) Records documenting the monitoring of CCP’s and their critical limits, including the recording of actual times, temperatures, or other quantifiable values, as prescribed in the establishment’s HACCP plan; the calibration of process-monitoring instruments; corrective actions, including all actions taken in response to a deviation; verification procedures and results; product code(s), product name or identity, or slaughter production lot. Each of these records shall include the date the record was made.

417.5(a)(2) The written HACCP plan, including decisionmaking documents associated with the selection and development of CCP’s and critical limits, and documents supporting both the monitoring and verification procedures selected and the frequency of those procedures.

Code: 01001
Violation: 416.1

Citation: Today at approx.0630 hrs. I performed inspection procedure (SPS) Verification, a hands on inspection verification of the establishment facilities for proper sanitation during operations in the plants processing environment and observed the following noncompliance: As I entered the blast cooler door located in the fin ished product packaging room observed foam/suds blowing out from the two overhead refrigeration un its located in said cooler. Upon further inspection I also noted that there was insanitary water dripping from the refrigeration un its. Said blast cooler had exposed ready to eat products staged in it to be packed during the days production. There was no product observed being affected at the time of my observation so no regulatory action was taken. [redacted] was informed of and observed this insanitary condition and took immediate corrective actions by removing the product from the area and notifying maintenance of the problem [redacted] was also informed that the establishment failed to meet the Federal Meat Regulations cited on th is noncompliance record.

Regulation:

416.1 Each official establishment must be operated and maintained in a manner sufficient to prevent the creation of insanitary conditions and to ensure that product is not adulterated.

Code: 01802
Violation: 416.13(c)

Citation: Today at approx.0600 hrs I performed inspection procedure 01802, a hands on inspection of the food contact surfaces for proper sanitation after the establishment had performed their preoperational inspection but prior to the start of operations in the establishments salad assembly room and observed the following noncompliance’s: 1.) Located in the salad assembly room inspection person nel observed on the stain less steel shelf located above the utensil wash sink where food contact utensils, (scoops and egg slicer) are stored prior to production, the utensils were observed sitting in a pool of standing water. Upon further inspection it was noted that there was product residues, (spinach and egg) from the previous days production floating in this standing water and on the utensils staged for use. Said residues were from approximately 1/4 inch to smaller in size and there were approximately ten pieces observed. 2.) Located in the salad assembly room product residues from previous days product was observed on the food contact surface of three gray plastic luggers. Said residues were approximately 1/8 inch to smaller in size and there were four to six pieces observed. Also observed during pre-op inspection was a sanitation performance standard, (SPS) noncompliance. The heat tunnel exhibited rust, dust, product residue, and black grease creating a insanitary condition in the exposed product production area [redacted]. was informed of and observed the pieces of equipment identified on this noncompliance record and took immediate corrective actions by washing and sanitizing the equipment restoring the sanitary condition in my presence. Upon review of the pre-op inspection record for this day indicated that the Sanitation SOP form used to document the findings during the plants pre-operational inspection and not been completed at the time of my observation. As indicated to [redacted] the establishment failed to meet 9 CFR 416.13(c) Implementation of SSOP’s and the establishments written SSOP plan which states; “4.1.1Equipment and facilities [redacted] . 4.1.3.1-at the start of each production day, . performs visual sanitation inspection on all cleaned and cleaned sanitized equipment and facilities.” The establishments pre-op inspection failed to identify the equipment that was not fully cleaned and sanitized.

Regulation:

416.13(c) Each official establishment shall monitor daily the implementation of the procedures in the Sanitation SOP’s.

NOTICE of SUSPENSION HELD in ABEYANCE:

On June 21, 2013, the Food Safety and Inspection Service (FSIS), Alameda District, notified your establishment of the suspension of the assignment of inspectors and the withholding of the marks of inspection, in accordance with Title 9 Code of Federal Regulations (CFR) Part 500.3 (b). This action was initiated due to your firm’s failure to prevent the inhumane handling and slaughtering of livestock at your establishment and to appropriately handle animals in accordance with Title 9 CFR Part 313.5(a)(3). This is in violation of 21 U.S.C. 603(b) of the Federal Meat Inspection Act (FMIA) and the Humane Methods of Slaughter Act of 1978, and the regulations promulgated thereunder.

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NOTICE of SUSPENSION:

This letter confirms the verbal notification provided to you on June 21, 2013, by the Food Safety and Inspection Service (FSIS), Alameda District, of the suspension of the assignment of inspectors at your establishment and the withholding of the marks of inspection for the slaughter operations, in accordance with Title 9 Code of Federal Regulations (CFR) Part 500.3 (b). This action was initiated due to your firm’s failure to maintain or implement requried controls to prevent the inhumane handling and slaughtering of livestock at your establishment and appropriately handle animals in accordance with Title 9 CFR 313.5(a)(3). This is in violation of 21 U.S.C. 603 (b) of the Federal Meat Inspection Act, and the Humane Methods of Slaughter Act of 1978, and the regulations promulgated thereunder.

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Code: 04804
Violation: 316.6, 317.2(i), 317.309, 316.10, 316.9, 317.308

Citation: The plant was producing a Macaroni and Beef Cassrole, in consumer size plates and there was no label with the ingredient statement and the inspection legend; there was no nutrition label content; and the wrong establishment number was being used; I observed a poultry label that was not legiable, the label did not have the required features of an approved label. 47 cases of product was retained with retain tag # B 25 455277. [redacted] was notified.

Regulation:

316.6 No person shall remove or cause to be removed from an official establishment any products which the regulations in this subchapter require to be marked in any way unless they are clearly and legibly marked in compliance with such regulations.

317.2(i) The terms spice, natural flavor, natural flavoring, flavor and flavoring may be used in the following manner

317.309(a) All nutrient and food component quantities shall be declared in relation to a serving as defined in this section.

316.10(a) Inspected and passed sausages and other products in casings or in link form, of the ordinary ‘‘ring’’ variety or larger shall be marked with the official inspection legend and list of ingredients in accordance with part 317 of this subchapter. The official marks required by this section shall be branded near each end of the sausage or similar product prepared in casings when the product is of a size larger than that customarily sold at retail intact.

316.9(a) Each carcass which has been inspected and passed in an official establishment shall be marked at the time of inspection with the official inspection legend containing the number of the official establishment.

317.308 The label of any package of a meat or meat food product that bears a representation as to the number of servings contained in such package shall meet the requirements of § 317.2(h)(10).

NOTICE of SUSPENSION HELD in ABEYANCE:

On April 03, 2013, the Food Safety and Inspection Service (FSIS), Alameda District, notified your establishment of the suspension of the assignment of inspectors and the withholding of the marks of inspection, in accordance with Title 9 Code of Federal Regulations (CFR) Part 500.3 (b). This action was initiated due to your firm’s failure to prevent the inhumane handling and slaughtering of livestock at your establishment and to appropriately handle animals in accordance with Title 9 CFR Part 313.30 (a)(4). This is in violation of 21 U.S.C. 603(b) of the Federal Meat Inspection Act (FMIA) and the Humane Methods of Slaughter Act of 1978 and the regulations promulgated thereunder.

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NOTICE of SUSPENSION:

This letter confirms the verbal notification provided to Mr. [redacted] General Manager, on April 3, 2013, by the Food Safety Inspection Service (FSIS), Alameda Distict of suspension of the assignment of inspectors at your establishment and the withholding of the marks of inspection for the slaughter operations, in accordance with Title 9 Code of Federal Regulations (CFR) Part 500.3(b). This action was initiated due to your firm’s failure to maintain or implement required controls to prevent the inhumane handling and slaughtering of livestock at your establishment and appropriately handle animals in accordance with Title 9 CFR 313.15. This is in violation of 21 U.S.C. 603 (b) of the Federal Meat Inspection Act (FMIA), the Humane Methods of Slaughter Act of 1978, and the regulations promulgated thereunder.

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