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WARNING LETTER

Bakkavor Foods USA Inc. MARCS-CMS 630545 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Renzo Anchirayco
Recipient Title
General Manager
Bakkavor Foods USA Inc.

2700 Westinghouse Blvd
Charlotte, NC 28273-0113
United States

Issuing Office:
Office of Human and Animal Food Operations – East Division 3

United States


August 08, 2022

RE: CMS #: 630545

WARNING LETTER

Dear Mr. Anchirayco:

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) dips, soups, salad bases, burritos, entrée style meals, and seafood products manufacturing facility located at 2700 Westinghouse Blvd, Charlotte, NC, 28273-0113, on February 7-11, 15, and 23, 2022. During our inspection, we collected environmental samples (swabs) from various areas in your facility. FDA laboratory analyses found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117) and Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123).

Based on FDA’s inspectional findings and the analytical results for the environmental swabs, we have determined that the ready-to-eat products manufactured in your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Furthermore, in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act (21 U.S.C. § 331(uu)). You may find the Act, further information about the CGMP & PC rule, and the seafood HACCP regulation through links in FDA’s home page at http://www.fda.gov.

At the conclusion of the inspection, the FDA investigators issued your facility a Form 483 (FDA-483), Inspectional Observations. You provided responses to the inspection and sample findings on March 16, April 16, May 13, and June 15, 2022, describing corrective actions taken by your firm. Based on our review of the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s continuing concerns and to provide detailed information describing the findings at your facility.

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):

1. You did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control, in accordance with 21 CFR 117.130(a)(1).

Specifically, your hazard analysis for “Ready to Eat Cold Salads, Sauces, Sides, and Dressings” at various processing steps (e.g., cold mixing, filling) determined that pathogens from “Environmental Cross-contamination” is a “Hazard Not Reasonably Likely To Occur due to lack of history with Food Contact Surface contamination with Listeria spp.” You also reference “Pre-Operational and Operational Sanitation Inspections” and “Good Manufacturing Practices” as “Control Measures in place.” Your sanitation inspections and GMPs are not preventive controls.

These RTE foods are exposed to the environment prior to packaging and do not receive a lethal treatment or otherwise include a control measure that would significantly minimize environmental pathogens. L. monocytogenes is a known or reasonably foreseeable pathogen associated with RTE foods (including RTE salads, sauces, dressings, and certain sides) exposed to the environment. Furthermore, RTE foods have been implicated in outbreaks of listeriosis, which can be a life-threatening illness. Thus, your hazard analysis should have determined that contamination with environment pathogens such as L. monocytogenes is a hazard requiring a preventive control (i.e., sanitation controls). Additionally, your hazard analysis must analyze other environmental pathogens, such as Salmonella. (See 21 CFR 117.130(c).)

Listeria monocytogenes in your facility:

To underscore the L. monocytogenes risk in your facility: FDA’s environmental findings indicate that you have a resident strain of L. monocytogenes in your facility, as well as transient strains.

FDA laboratory analysis of environmental sample 1171734 collected on February 8, 2022, from various areas in your processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed fourteen (14) of one-hundred ten (110) environmental swabs were positive for L. monocytogenes. These locations include areas where products are exposed to the environment prior to packaging in your production room, (b)(4) room, work in progress (WIP) cooler, and (b)(4) room. This was not the first time L. monocytogenes was found in environmental samples collected at your facility.

Environmental swabs collected also revealed L. monocytogenes in this facility as follows:

  • 2019, four (4) out of one-hundred five (105) swabs collected by the North Carolina Department of Agriculture & Consumer Services (NCDA) from non-food-contact surfaces, including the floors and drains
  • 2016, eight (8) out of one-hundred seventy-eight (178) swabs collected by NCDA from non-food-contact surfaces, including the floors and drains
  • 2009, six (6) of forty (40) swabs collected by FDA from non-food-contact surfaces, including the floors and drains
  • 2008, eight (8) of fifty (50) swabs collected by FDA from non-food-contact surfaces, including the floors and drains.

Whole genome sequencing (WGS) was conducted on the above referenced L. monocytogenes isolates, except for the 2016 isolates where sequence data was not available. Based on the results of the WGS analysis, the thirty-one (31) isolates represent six (6) strains of L. monocytogenes. One strain of particular significance represents ten (10) isolates derived from the swabs collected at your facility during our February 2022 inspection, including the two (2) RTE food-contact surface positives, which were determined to match isolates derived from swabs collected by the NCDA in 2019 and FDA in January 2009. The presence of the same strain of L. monocytogenes over multiple years is indicative of a resident pathogen in your facility. Two of the strains represent four (4) isolates from the swabs collected in February 2022 and do not match any other isolates in the database. Three of the strains represent twelve (12) isolates from the swabs collected in 2008 and 2009 and do not match any other isolates in the database. We advised you of the importance of these WGS results via a conference call on March 10, 2022 and provided updated WGS results via conference call on June 24, 2022.

Moreover, in reviewing your facility’s own environmental monitoring test results, we noted that you have repeatedly found Listeria spp. through your own testing. For example, Listeria spp. was found in or on:

(1) The condensation lines and the floors beneath evaporators.
(2) The WIP cooler floor, including on the condensation line terminus and the floor drain.
(3) The food contact surface of the cheese grinder.
(4) The food contact surface of the (b)(4) tumbler seal and the inside of the lid.
(5) The framework of the (b)(4) line.

Your Listeria spp. findings can, in part, be attributed to the insanitary conditions observed during the inspection which are discussed further in the “Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)” portion of this letter.

Inadequate responses to L. monocytogenes-positive test results:

The reoccurring presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation procedures have been inadequate to protect against L. monocytogenes in your facility. Once L. monocytogenes is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism is able to survive, and to take corrective actions as necessary to eradicate the organism by rendering these areas unable to support the survival and growth of the organism and prevent the organism from being re-established in such sites.

In response to positive environmental monitoring test results, you have generally performed (b)(4) swabbing, recleaning/sanitizing, and reswabbing. However, it appears your corrective actions have not been adequate to address the presence of L. monocytogenes. For example, according to your “Environmental Monitoring Corrective Action Follow Up Records” for your Listeria spp. positive swabs, you attributed many of the positive swabs to employee practices, condensation, and inadequate equipment condition and sanitation. Your actions in response to the positive findings included intensified cleaning, revising cleaning procedures (SSOPs), reminders to follow your SSOPs, and updating your pre-operational inspection. Your “Cleaning and Sanitation” procedure states that for each shift a “(b)(4) Shift Good Manufacturing Practice inspection is conducted by the QA department” which includes “cross contamination, food contact surfaces, and condensation.” Any incident that is determined to be outside acceptable parameters will be recorded on the (b)(4) form as a non-compliance and corrective actions are required. Nevertheless, during the February 2022 inspection, our investigators observed employee practices, condensation, and inadequate sanitation that could lead to cross-contamination of food-contact surfaces and RTE food and which were not noted on your (b)(4) inspection form.

Furthermore, according to your “Cleaning and Sanitation” procedure, food-contact surfaces, utensils, equipment, and accessories are deep-cleaned (b)(4) and the cleaning is recorded on the “Sanitation and Pre-Operational Inspection log.” Any deficiency is to be documented on the “Pre-Operational Inspectional Log” and reviewed by the QA supervisor or Manager. Other cleaning is captured on the “Master sanitation schedule,” such as cleaning of the WIP cooler, drains, and evaporators. “If any gaps are found, where an area / item of equipment has not been cleaned in the frequency donated [sic] by the logs, then the site QA team will issue a Non-Conformance. This should be investigated, and corrective action will be recorded to prevent reoccurrence. The schedule will be adjusted to ensure the clean is completed immediately.” During our February 2022 inspection, the “Post-Sanitation Pre-op Inspection Form” from February 10, 2022 was reviewed noting equipment as acceptable for use; your inspection did not reveal any of the insanitary conditions referenced below. In addition, you did not have any records documenting master sanitation of the WIP cooler from April 3, 2021 to October 20, 2021, and the week of January 31, 2022. No actions were taken in response to the gaps in sanitation or sanitation inspection.

Your response to the FDA-483 and your corrective actions:

Your March 16, 2022 written response to the FDA-483 stated an expert biologist performed a critical evaluation of your facility to assess your environmental pathogen monitoring program and historical results to identify root causes of reoccurring Listeria spp. findings. You identified the two root causes as: (1) Remote from food and food-contact surfaces, build-up of organic matter due to lapses in deep cleaning activities that were not clearly defined on the Master Cleaning Schedule and (2) Failure to detect Listeria spp. in your routine environmental pathogen surveillance program due to inadequate representation of non-food-contact surfaces.

In addition, your written response stated that during the inspection there were gaps in your sanitation standard operating procedures (SSOPs) for the sanitation of the conveyors on the (b)(4) line and (b)(4) lines, cleaning water-sensitive equipment such as the control panels, and routine cleaning of your evaporators. You provided SSOPs for these areas with employee training records. You also removed some equipment and utensils where L. monocytogenes positive swabs were collected. Further, you indicated that you hired a new Sanitation Manager and additional staff to monitor and correct any pooling water or condensation throughout the plan during production. You have also made additional facility and equipment improvements to address pooling water and condensation. You also indicated that “Due to staffing turnover, deficiencies in training (which have been identified and addressed), and a leadership gap in sanitation and quality assurance management (which has also been addressed), documentation was not completed adequately.” Although you state you have made improvements to your cleaning and sanitation program and documented extensive training associated with these procedures and provided records demonstrating the implementation to date, it is important to note that long-term implementation, such as with sanitation preventive controls and associated management components, will be critical to the success of your program. (See 21 CFR 117.135(c)(3) and 117.140.)

You also provided your updated “Environmental Pathogen Monitoring Program” to specify that environmental monitoring corrective actions must be taken and documented, including a review and approval by senior leadership. You stated the environmental monitoring program has been revised to represent non-food-contact surfaces which are beyond those that are adjacent to food or food-contact surfaces, including sites where FDA sampling identified L. monocytogenes. You stated that you contracted with a third-party sanitation company to perform enhanced sanitation of the facility on (b)(4). You provided the results of (b)(4) environmental swabs tested for Listeria spp. to support the effectiveness of the enhanced cleaning. However, you have not provided a written environmental monitoring plan and results verifying that your revised cleaning and sanitation procedures are adequate to significantly minimize or prevent the hazard of environmental pathogens, even though contamination of RTE food exposed to the environment with an environmental pathogen is a hazard requiring a preventive control. (See 21 CFR 117.165(a)(3) and (b)(3).)

Given the history of our findings and the presence of L. monocytogenes in your facility, we continue to be concerned about your ability to maintain a sanitary environment. Your written responses did not fully explain how you investigated the source of the resident L. monocytogenes, demonstrate that you have located and eradicated the harborage site(s), or provide supporting documentation to show implementation and verification of adequate corrections (e.g., revised Food Safety Plan or routine environmental sampling results). We recommend that you continue to conduct a root cause analysis into potential harborage sites and source(s) of the organism in your processing environment. We remind you that environmental sampling is most effective at identifying pathogens when extensive sampling occurs several hours into production, because production activities may dislodge pathogens from harborage sites. You must implement an adequate Food Safety Plan to ensure foodborne pathogens do not contaminate your RTE food products. Your record keeping in accordance with 21 CFR part 117 will be critical to demonstrate the implementation of corrective actions consistently over time. We will verify the effectiveness of your corrective actions and your ability to maintain a sanitary environment during our next inspection.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

1. You did not clean and sanitize equipment in a manner that protects against contamination of food-contact surfaces, as required by 21 CFR 117.35(a).

Specifically, during the February 2022 inspection our investigators observed (b)(4) hose nozzles, used for rinsing RTE food contact equipment, stored on the floor: in the (b)(4) area, between the (b)(4) lines in the production room, next to a trash cart in the production room, and in the kettle room. On February 10, 2022, an employee used a nozzle from the floor to clean/rinse the depositor pump parts that were stored on a prep table in the staging area of the processing room, then return the hose to the floor. The parts were subsequently sprayed with sanitizer, but in a manner that did not adequately coat all food-contact surfaces. You routinely collect Listeria spp. positive swabs from floors and drains throughout your facility, including at least (b)(4) in 2021-2022.

In your May 13, 2022 response, you provided an update on the installation of hose reels and new shorter hoses to prevent hoses from being utilized across extended distances. You reported as of May 5, 2022, (b)(4) hose reels have been installed. (b)(4). You also provided documentation of employee training for the storage of hoses used in cleaning and sanitizing equipment. We will verify the effectiveness of your corrective actions during our next inspection.

2. Your plant is not constructed in such a matter that drip or condensate from fixtures, ducts and pipes does not contaminate food and food-contact surfaces, as required by 21 CFR 117.20(b)(4).

Specifically, our investigator observed excessive condensation on the ceiling and evaporators throughout your facility directly above RTE product and food-contact surfaces, including in the WIP cooler and over unprotected, cleaned, and sanitized RTE food-contact bins in the (b)(4) washroom. Also, condensation was observed on the ceiling above the (b)(4) hopper for the (b)(4) machine where RTE (b)(4) and (b)(4) are manufactured.

In your March and April response letters, you stated that you have added (b)(4) personnel to monitor and correct condensation and pooling. You also included copies of SOPs relating to monitoring and controlling condensation. Furthermore, you stated that your evaporators were inspected for catch pans and you have created a schedule to service them routinely. You described installing a (b)(4) and a (b)(4) to help control condensation. Finally, you stated that you plan to (b)(4) for the WIP cooler to help eliminate condensation. You should continue to monitor for condensation and evaluate if additional corrective actions should be taken to ensure food is not exposed to condensate drip. We will verify the effectiveness of your corrective actions during our next inspection.

3. You did not conduct all food manufacturing and processing under such conditions and controls as are necessary to minimize the potential for contamination of food, as required by 21 CFR 117.80(c)(2).

Specifically, our investigator observed that while walking across the floor of the WIP cooler, employees splashed pooled water onto trays of in-process RTE food (prior to packaging) stored on rolling racks in the cooler. The pooled water appeared dirty and contained food residue.

In your March and April response letters, you stated that you had your floor leveled and regraded to eliminate the possibility of run-off of water into the WIP cooler. You stated you also have added (b)(4) personnel to monitor and correct condensation and pooling. Finally, you indicated that you now leave the (b)(4) racks empty of food to prevent contamination from floors. We will verify the effectiveness of your corrective actions during our next inspection.

4. Your plant equipment and utensils used in manufacturing and processing are not designed and of such material and workmanship as to be adequately cleanable, and adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1).

Specifically, our investigator observed apparent rust on the food-contact parts of the Cheese Grinder (b)(4) and its outlet port. They also observed that the (b)(4) on the (b)(4) tumblers which hold RTE food were damaged, making them difficult to clean.

In your March response letter, you stated that you decommissioned the cheese grinder on February 28, 2022 and reformulated product to use pre-shredded cheese. You also stated that you replaced the (b)(4) on March 7, 2022. You also noted that you retrained personnel on pre-op inspections. We will verify the effectiveness of your corrective actions during our next inspection.

5. You did not clean non-food-contact surfaces of equipment used in the operation of a food plant in a manner and as frequently as necessary to protect against contamination of food and food contact surfaces, as required by 21 CFR 117.35(e).

Specifically, our investigator observed apparent food residue remaining on the inside cup holder framework of the (b)(4) machine where RTE (b)(4) and (b)(4) dip are packed, as well as on the conveyor belts and framework for (b)(4) lines (b)(4), after pre-op inspection and release by quality assurance on February 10, 2022. They also observed apparent old and fresh product and black residue on the wheels of the conveyors for the (b)(4) line and the (b)(4) lines after pre-operation inspection and release by quality assurance on February 10, 2022. The wheels contact the outer/food-contact surface of the belts.

In your March letter, you stated that you retrained your employees on proper cleaning procedures for the (b)(4) machine and other impacted areas. You also explained that you had no SSOP for cleaning the conveyor at the time of the inspection. You stated that you have since created an SSOP and provided training on (b)(4) and (b)(4). We will verify the effectiveness of your corrective actions during our next inspection.

Seafood HACCP ((21 CFR Part 123):

1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point (CCP) is defined in 21 CFR 123.3 (b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.” Your HACCP plan, “USDA/FDA/Seafood RTE Cold Mixing- Comprehensive” covers the processing of your RTE products, including bulk tuna Salad and hot-filled soups containing crab, clam, and lobster. However, your HACCP plan fails to list a CCP for finished product storage of your RTE seafood products to control the hazards of pathogen growth and toxin formation including Clostridium botulinum, and histamine formation. This is a repeat violation that was noted in your 2010, 2012, 2015, and 2019 inspections.

Additionally, every processor shall have and implement a written HACCP plan for each kind of fish and fishery product processed by the processor. Grouping kinds of fish and fishery product together, is allowed when the food safety hazards, CCPs, critical limits and procedures for monitoring, verification and recordkeeping are identical for all fish and fishery products grouped for all production methods, to comply with 21 CFR 123.6 (b)(2). However, your HACCP plan grouped all RTE seafood products produced into one HACCP plan along with your other RTE foods when the hazards, CCPs and controls are not identical.

For example, your hot-filled soups likely require CCPs for cooking to control for pathogen survival, cooling to control pathogen growth and toxin formation, hot filling to control for recontamination by pathogens, packaging in containers with a sealed (b)(4) to control for C. botulinum and finished product storage to control for pathogen growth and toxin formation including C. botulinum. Whereas your bulk tuna salad likely requires CCPs for acidification to control non-proteolytic C. botulinum in the bagged finished bulk salad (depending on the oxygen transmission rate of bag) and finished product storage to control for pathogen growth and toxin formation (likely including proteolytic C. botulinum growth) and histamine formation. Having individual seafood HACCP plans and hazard analysis for properly grouped products ensures that all reasonably likely to occur hazards are properly controlled. It is difficult to determine the exact reasonably likely to occur hazards in your RTE seafood products and the associated needed controls when your hazard analysis groups all products together without specifying which products have which hazards.

Ensuring all reasonably likely to occur hazards are controlled in a seafood HACCP plan is critical because your firm produces seafood soups that are cooked for the target pathogen of L. monocytogenes, then hot filled into containers with a sealed (b)(4), which is considered reduced oxygen packaging; thus, creating the reasonably likely to occur hazard of C. botulinum. However, your firm does not acknowledge the hazard of C. botulinum, nor does it have adequate controls (e.g., water activity, or a cook that targets non proteolytic C. botulinum, or temperature control below 38°F with the use of time temperature indicators on each package). Non proteolytic C. botulinum can grow at a minimum temperature of 38°F and will grow and produce a deadly toxin after two days when temperatures are between 42-50°F and 11 hours when the temperature is increase to between 51 and 70°F. For L. monocytogenes, the time and temperature limit is one day at temperatures between 42-50°F and just 7 hours when the temperature is between 51-70 °F before the product is considered unsafe and temperature abused. Your firm’s lack of controls for pathogens including C. botulinum, and histamine is very concerning based on the evidence below for your finished product cooler that was found to have the continuous temperature monitoring device disconnected for at least the (b)(4) and was found to have extensive temperatures excursions above (b)(4)°F in (b)(4), without taking corrective actions to ensure adulterated product did not enter commerce and the cause of the deviation was corrected to prevent recurrence.

Although, your hazard analysis incorrectly identified the hazards associated with finished product storage as, “Hazard Not Reasonably Likely to Occur (HNRLTO) due to lack of firm history with incidence of storage temperatures above (b)(4)°F during storage temperature checks” you have developed procedures for monitoring the temperature of your finished product cooler. Your procedure for storage, “Storage and Handling of Goods” states that cooler temperatures should be set at or below (b)(4)⁰F. Your procedure for temperature monitoring, “Environmental Temperature Monitoring,” states that cooler temperatures will be monitored (b)(4), and if found out of specification it will be rechecked in (b)(4).

Nevertheless, our investigators observed several deviations of refrigerated finished product storage and implementation of your firm’s written temperature control procedures as follows:

  • The finished product cooler continuous temperature monitoring device had been disconnected since (b)(4), management was unaware, and the records are not reviewed by quality assurance. The tuna salad and hot filled soups are stored in this cooler for up to (b)(4) to shipping.
  • Review of your firm’s finished product cooler temperature monitoring logs from September 2021 found approximately (b)(4) out of (b)(4) temperatures documented over (b)(4)F. These records also indicated that the recorded temperatures were frequently in the range of (b)(4)°F for (b)(4) with a maximum of (b)(4). Additionally, your shipping records indicate that you manufactured and stored your RTE tuna salad in the finished product cooler with these temperature deviations for (b)(4) to (b)(4) days in September of 2021. Finally, your firm did not have any corrective actions to ensure unsafe product was not distributed and your HACCP plan was reassessed as required by 21 CFR 123.8 (a).
  • The finished product cooler temperature was not rechecked within (b)(4) hours after exceeding (b)(4)°F according to your procedures on the following dates: (b)(4). The records were reviewed by QA; however, no deviations were noted.
  • You did not visually monitor the temperature of the finished product cooler (b)(4) according to your procedure, where tuna salad and hot filled soups may be stored for up to (b)(4), on the following dates: (b)(4).

We acknowledge your response indicates you performed a reassessment of the Seafood HACCP plans and a CCP for continuous monitoring of stored product was added to prevent temperature deviations, which could cause bacteria outgrowth and toxin formation. In addition, you reported finished product shipping temperature control was added as a CCP to prevent any nonconforming product from entering commerce. This update was promised to be implemented by March 21, 2022.

You provided a screen shot of CCP 1 “Product Refrigerated Storage”, and CCP 3 “Refrigerated Shipping (Finished Product)” in addition to an employee training record for temperature monitoring. However, the revised CCP 1 is not adequate because it lists the option of the QA tech taking the cooler air temperature (b)(4). The ambient temperatures of the cooler should be continuously monitored with a visual check of the data at least daily.

Additionally, you have not provided complete revised seafood HACCP plans. You should, at a minimum, have a product flow chart, hazard analysis and HACCP plan specific to your bulk Tuna Salad and another product flow chart, hazard analysis and HACCP plan specific for your hot-filled soups containing seafood and possibly additional seafood HACCP plans and associated documents for other seafood products you process. You must ensure your seafood HACCP plans specifically address the seafood products you process and clearly identify the reasonably likely to occur hazards associated with the seafood products as required by 21 CFR 123.6 (a) and (b). To assist you with complying with 21 CFR 123.6, we suggest that you use FDA’s Fish and Fishery Products Hazards and Controls Guidance to create your new seafood HACCP plans. As part of your response, you should provide your revised seafood HACCP plans including supporting documentation (e.g., product flow chart and hazard analysis) for all seafood products processed at your facility.

We also acknowledge in your written response that you implemented a (b)(4) temperature verification program to monitor temperature in the A La Carte, Finished Goods Storage, and Shipping areas as well as added temporary chilled storage on-site to store product while the deficiencies are being corrected. Further you mention you invested in temporary data logging systems where quality assurance will retrieve data (b)(4). Also, you stated you invested in repairs to the refrigeration system with the addition of (b)(4) evaporator coils and corresponding condensing units across the (b)(4), Finished Goods, and Shipping areas. All units were installed and operational as of May 6, 2022. You reported your temperature monitoring system was fully implemented on April 21, 2022, in coordination with the evaporator and condenser unit completion. However, in your response you repeatedly mention, due to staffing turnover and deficiencies in training, documentation was not completed adequately during and prior to the current inspection. You provided training/retraining records for employees as well as SSOPs as it relates to shipping inspection forms for finished product temperature and corrective actions when deviations occur. Although, you have committed significant resources to enhance temperature monitoring, we remain concerned about the implementation of this corrective action over time. It is your responsibility to ensure your employees are trained in their job functions and they are monitored to ensure they are consistently performing them in accordance with the regulations and your procedures, regardless of staffing turnover.

Furthermore, as part of ensuring proper sanitation is consistently implement by your employees, you should have sanitation control procedures for your RTE seafood products that comply with 21 CFR 123.11. The conditions and practices during processing are to be monitored with sufficient frequency to ensure, at a minimum, compliance with these conditions and practices specified in 21 CFR 117, that relate to: 1) the safety of water; 2) the condition and cleanliness of food contact surfaces; 3) prevention of cross-contamination from insanitary objects to food, food packaging, and food contact surfaces; 4) maintenance of hand washing, hand sanitizing, and toilet facilities; 5) protection of food, food packaging material, and food contact surfaces from adulteration by condensate and other chemical, physical, and biological contaminates; 6) proper labeling, storage and use of toxic compounds; 7) employee health; and 8) exclusion of pests, to comply with 21 CFR123.11 (b). However, your provided examples of your (b)(4) Master Sanitation Schedule and your Post Sanitation Pre-Op Inspection records, which monitor the cleaning of floors, walls, ceiling, equipment, and utensils, fail to monitor the other seven key areas of sanitation as required by 21 CFR 123.11 (b). Additionally, in your response to the observations of excessive condensate dripping throughout your facility including into RTE food and food contact surfaces, you provided an example of a newly created SSOP Monitoring record for Condensation and Standing Water that records the clean-up of standing water or condensate. This record is not adequate for sanitation monitoring because it records the clean-up, which is a corrective action, and not the consistent monitoring for drips of condensate and water to protect food, food packaging, and food contact surfaces from adulteration with condensate and other contaminates as required by 21 CFR 123.11 (b)(5). As part of your response, you should provide your revised sanitation monitoring for your RTE seafood products for at least (b)(4)’ worth of monitoring. For assistance with complying with 21 CFR 123.11 (b), we suggest you review the Seafood HACCP Alliance course document “Sanitation Control Procedures for Processing Fish and Fishery Products.” We will verify the totality and adequacy of these corrective actions during our next inspection.

This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your facility complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections.

Your written response should be sent to Victoria L. Palmer, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, NE, Atlanta, GA 30309. If you have any questions regarding the content of this letter, please contact Victoria L. Palmer. at 404-253-1173 or email victoria.palmer@fda.hhs.gov.

Sincerely,
/S/

Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3

Cc:
Anita MacMullan, Director
North Carolina Department of Agriculture and Consumer Services
4400 Reedy Creek Road
Raleigh, NC 27607

 
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