The Food and Drug Administration recently sent warning letters to a seafood processor in Chile, Greece, and India and a Ready-To-Eat (RTE) salad, sandwich, and institutional meals manufacturing facility in New York because inspectors found significant violations of U.S. food safety laws at their operations.
Businesses have 15 days to respond in writing to the FDA after receiving a warning letter. If they don’t correct the violations, the FDA can take action up to and including shutting down operations.
In a warning letter dated Aug. 19, 2019, the FDA informed Director Rodrigo Becerra that Commercial Mares de Chiloe’s HACCP plan, entitled “Quality Assurance Manual Based on HACCP” for their salmon and trout products, which are intended to be consumed raw or cooked, shipped refrigerated or frozen, and maybe vacuum packaged, demonstrates serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. Accordingly, the firm’s salmon and trout products are adulterated in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
Pathogen growth is reasonably likely to occur in fish and fishery products that are exposed to unrefrigerated temperatures (e.g. temperatures above 4.4°C (40°F) for unsafe periods of time. FDA inspectors suggested that the firm’s HACCP plan include appropriate controls to ensure that each product is appropriately labeled with handling instructions (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use”), so it is not conducive to C. botulinum growth and toxin formation. Additionally, the FDA recommended that the firm’s HACCP plan include controls for parasites in their ready-to-eat refrigerated salmon products.
Additionally, FDA noted that on July 10, 2019, the FDA placed Commercial Mares de Chiloe on the red list of Import Alert 16-39 “Detention Without Physical Examination of Processed Seafood and Analogue Seafood (Surimi) Products for Listeria Monocytogenes” based on evidence which identified Listeria Monocytogenes in analyzed portions frozen raw salmon intended for raw consumption.
“Your response should outline the specific things you are doing to correct these violations, ” the FDA warned. “More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as documentation reflecting the changes you made, such as a copy of your revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of 5 production date codes of products) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation.”
Pavlos Trifonidis S.A in Kava la, Greece is on notice from the FDA because of significant deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation under the Federal Food, Drug, and Cosmetic Act (the Act). The firm processes fish products, which must have a HACCP plan that complies with the Act.
FDA acknowledged receipt of an email response sent from the firm via email on April 5 and June 10, 2019; “Your responses included revised HACCP plans along with corresponding HACCP documents. However, our evaluation of your response revealed it was not adequate, as further described in this letter.”
Staff from the Food and Drug Administration inspected the firm’s facility on March 14 and 15, 2019, and rendered the firm’s tuna “Lakerda (Thunnus alalunga)” packed in oil and canned salted anchovies products adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
The FDA noted several significant deviations:
“The maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.” However, the firm’s revised HACCP plan provided with their June 10th response for critical limit for a core temperature of the fish is not appropriate to control scombrotoxin (histamine) formation.
“FDA recommends a critical limit that ensures the product is held at a continuous cooler temperature of 40°F (4.4°C) or below, or ensure the product is completely and continuously surrounded by ice throughout the storage time.”
Additional critical limits submitted by the firm were not adequate by themselves to control scombrotoxin (histamine) formation when receiving fresh fish from the harvest vessel; In addition to taking the internal temperature of incoming scombroid species fish, FDA recommends conducting a sensory examination of a representative number of incoming fish for decomposition.
“Lastly, when processors rely on the adequacy of ice during transit from the harvest vessel to the plant, FDA recommends a critical limit that lists fish are to be completely surrounded by ice during transit and at the time of delivery.”
At the end of the warning letter, the FDA warned that if the firm does not respond, or if the FDA finds their response inadequate, further action may be taken; “For instance, we may take further action to refuse admission of your imported fish or fishery products.”
In Aug. 22 warning letter to Managing Director Dattubhai Tandel, FDA investigators noted significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation after an inspection of Shree Datt Aquaculture Farms on May 15 through 16, 2019.
“At the conclusion of that inspection, the FDA investigator issued an FDA 483, lnspectional Observations, listing the observations made at your firm. We acknowledge receipt of your responses sent via email on May 30, 2019, and July 20, 2019, to FDA 483 and to the FDA email dated July 2, 2019,” however, the firm’s July 20, 2019 revised HACCP plan, written corrective action report, cooking validation record, and completed monitoring records, revealed they were not adequate.
Accordingly, the firm’s cooked shrimp are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.
The FDA noted that the firm revised HACCP plan entitled “Cooked and Peeled /PD PV/PND/PDTO/PDTO BFLY IQF” dated July 5, 2019 lists monitoring procedures and frequencies that are not adequate to control pathogenic bacteria survival through cooking.
As noted, FDA recommends that firms monitor the cooking temperature (steam temperature) using a continuous temperature-recording device (e.g., a recording thermometer) with continuous monitoring by the device itself with a visual check of the recorded data at least once per day. Investigators added that monitoring the belt speed with a stopwatch does not ensure conformance with the firm’s listed critical limit for the [undisclosed] time for the products to be held at a listed core temperature of 79 Degrees C; “Monitoring the belt speed with a stopwatch will only indicate how long the product was in the cooker.”
The firm’s response to the FDA should include documentation reflecting the changes made, such as a copy of their revised HACCP plan, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the products) to demonstrate implementation of the plan, and any additional information that the firm wishes to supply that provides assurance of their intent to fully comply now and in the future with the applicable laws and regulations.
“If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported fish or fishery products,” FDA officials warned.
In a warning letter dated Aug. 9, 2019, the FDA informed President and Chief Executive Officer, Mr. Paul J. Whitcomb, that FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. Additionally, FDA collected environmental samples from various areas in the firm’s facility “including food contact surfaces and areas that are near food during processing operations,” and FDA laboratory analyses of the environmental samples (i.e., swabs) identified the presence of Listeria monocytogenes, a human pathogen.
According to emails the FDA received on November 4, 9, 12, 13, December 7, 9, 11, and 12 of 2018, the firm said they have hired consultants, performed an investigation of the processing facility and equipment including sampling for L. monocytogenes harborage sites, cleaned and sanitized their processing environment, conducted environmental sampling and finished product testing for L. monocytogenes, developed a maintenance schedule and planned improvement program, repaired equipment and floors, updated their procedures including their environmental sampling program, reassessed all food safety plans (including your “HARPC” and Seafood HACCP plans), and conducted training.
The FDA addressed the firm’s responses below, nothing the following significant violations:
- The firm’s food safety plan for RTE Thai Noodle Salad and Macaroni and Cheese did not identify a preventive control for the food safety hazard of contamination of RTE products with an environmental pathogen, e.g., L. monocytogenes; “These RTE products are exposed to the production environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure.”;
- The reoccurring presence of identical strains of L. monocytogenes in the firm’s finished products and manufacturing environment indicates that niche harborage sites are present in their facility; “Furthermore, these repeated findings of L. monocytogenes in your environment and RTE product should have resulted in a reanalysis of your food safety plan, and the identification of contamination of RTE products with environmental pathogens as a hazard requiring a preventive control”;
- The firm did not implement their preventive controls for allergens; “Your preventive controls require that your labels contain an allergen declaration,” However, during the FDA’s inspection observing the manufacturing, packaging, and labeling of RTE Thai Noodle Salad (a pasta salad containing wheat and soy allergens), the label affixed to the product that was ready for distribution did not contain a list of ingredients or an appropriate allergen declaration;
- The firm’s plant was not kept in repair adequate to prevent food from becoming adulterated, as required under CGMP regulations; “During our inspection, on October 30, 2018, we observed two holes in the floor of the salad room where exposed RTE salads are processed. These holes were swabbed (swab # 122) and found positive for L. monocytogenes.”; and
- The firm’s critical limit, under Seafood HACCP, does not ensure that the refrigerated finished products (e.g., tuna salad sandwich and various vegetable salads containing tuna salad) have a pH of 5.0 or less to control non-proteolytic C. botulinum during distribution; “The critical limit only addresses the tuna salad pH and does not address the pH of the interface of the tuna salad with the other meal components which could increase the pH of the tuna above 5.0.”
FDA noted that the warning letter is not intended to be an all-inclusive list of violations at the firm’s facility or in connection with their products; “You are responsible for ensuring your facility operates in compliance with the Act, the CGMP, the PC rule, the seafood HACCP regulation, and other applicable laws.”
Lastly, FDA officials added that the firm should take prompt action to correct the violations noted in this letter, and that failure to do so may result in regulatory action without further notice, including without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
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