The Food and Drug Administration recently sent warning letters to a Florida bakery, a New York ready-to-eat (RTE) food manufacturer, and seafood processors in Maine and Korea 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.

Atlantic Bakery ltd., doing business as Old School Bakery — Delray Beach, FL
Inspectors found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, in addition to misbranding; “Based on FDA’s inspectional findings, we determined that your food products manufactured in your facility are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health.”

The FDA sent a warning letter dated July 12, 2019 to the bakery owner William B. Himmelrich, informing him of multiple violations after inspecting the facility Dec. 28, 2019 through Feb. 5, 2019 and obtaining product labeling and manufacturing records for several of the bakery’s RTE products.

Those violations include:

  • After reviewing labels and documents, the FDA found that products manufactured and distributed by the firm are not labeled in accordance with the Code of Federal Regulations; “Therefore, your RTE bakery products are misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 343, in that they are not labeled with the mandatory information required by the Act.”
  • The FDA received a response from the firm on March 01, 2019, addressing the labeling deviations discussed during inspection and during a closing meeting held on February 05, 2019; “We have found your response inadequate in that it is not specific for the corrections you will be implementing to fully correct your labeling issues. Your response indicates that you have developed a solution to list all ingredients and allergens on each item delivered. It is not clear if you are referring to a label, and if this label meets the requirements established in the Act and applicable regulations. There is no graphic evidence submitted along with your response to evaluate your labeling corrective and preventive actions. According to your response, you are working with a software provider to develop a permanent solution for the labeling issues. However, the solution and expected implementation date are not known.”;
  • The CGMP & PC rule provides that the firm must conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the firm’s facility to determine whether there are any hazards requiring a preventive control; “The CGMP & PC rule further provides that you must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated.”;
  • The firm did not prepare, or have prepared, and did not implement a food safety plan for the food products manufactured in their facility (including Crisp Sundried Tomato Cheese Bread, Crisp Cinnamon Bread, Challah Bun Round Plain, Potato Bun, and Brioche Bun products);
  • The firm’s food products may have biological, chemicals (i.e., mycotoxins), and physical hazards which could require process, allergen, sanitation, and supplier controls;
  • The firm did not did not conduct a hazard analysis for any of their products; “You did not identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control.”;
  • The firm appeared to have hazards requiring preventive controls, but did not identify and implement preventive controls for any of their products to provide assurance that any hazards requiring a preventive control will be significantly minimized or prevented;
  • The firm did not maintain their plant in a clean and sanitary condition;
  • The firm did not take adequate precautions to ensure that production procedures did not contribute to contamination;
  • The firm’s equipment and utensils were not designed and constructed to be adequately cleanable and were not adequately maintained to protect against contamination; and
  • FDA investigators noted Misbranding Violations for several products, which can be read in full at the bottom of the warning letter.

U.F.S. Industries, Inc. doing business as, Sally Sherman Foods — Mount Vernon, NY
In a warning letter dated July 30, 2019, the FDA informed owners Mr. Felix Endico and Mr. William Endico that their company’s production of RTE salads and prepared foods products were under serious violations of the Current Good Manufacturing Practice, Hazard Analysis, Risk-Based Preventive Controls for Human Food regulation, the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

Additionally, “The FDA collected environmental samples from various areas in your facility, including areas that are near food during processing operations and your food contact surfaces. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility.”

The FDA noted an email response from the firm in regards to the Listeria sample findings including written summaries of corrective actions, sanitation and cleaning procedures, environmental swab and finished product testing results. However, the FDA found the firm’s responses either inadequate or did not have sufficient information to determine the adequacy of their corrective actions for the reasons further discussed below.

Violations documented by FDA inspectors included, but are not limited to:

  • In the firm’s food safety plan, they did not identify and implement a preventive control for the food safety hazard of contamination of RTE products with an environmental pathogen, such as Listeria; “As evidenced by environmental findings that indicate a strain of L. monocytogenes in your facility, you did not implement sanitation controls adequate to ensure that your facility is maintained in a sanitary condition to significantly minimize or prevent the hazard of the environmental pathogen L. monocytogenes.”;
  • FDA findings demonstrate that the firm’s sanitation procedures have been inadequate to significantly minimize or prevent Listeria in their facility;
  • The firm did not implement adequate written procedures for product testing and environmental monitoring;
  • The firm’s allergen controls procedures did not include appropriate controls for protection of food from allergen cross-contact;
  • The firm did not conduct and document appropriate supplier verification activities;
  • The firm’s cold storage unit used to store and hold food did not have a temperature device installed to show temperature accurately;
  • The firm’s plant was not constructed and designed to facilitate maintenance and sanitary operations for food-production purposes;
  • Employees were observed using high pressure water hoses to spray floor areas in the RTE processing facility in close proximity and directly next to equipment and food contact surfaces; and
  • The FDA observed the firm manufacturing products “Krabmeat Salad” and “Tuna Salad” that are both subject to seafood HACCP regulations, and observed several significant deviations.

Port Clyde Fresh Catch, Inc. — Port Clyde, ME

FDA inspectors found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation; “Accordingly, your refrigerated, ready-to-eat, cooked crabmeat and frozen, ready-to-eat crabmeat in vacuum packages are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may be rendered injurious to health.”

The FDA acknowledged a receipt of the firm’s written response, received in the FDA office on May 17, 2019, to the deviations observed during the inspections on April 16 – 18, and 25, 2019, and evaluated their response of corrective actions relative to the following violations:

  • The firm must have a HACCP plan that, at a minimum, lists the critical limits that must be met; “When this information was brought to management’s attention you did not take corrective action and your firm continued to process, package, and ship the batches of ready-to-eat crabmeat from the batches listed above.”;
  • The critical limit continues to be inadequate because it continues to lack a time parameter; “FDA recommends the product be cooled from 135° F to 70° F within 2 hours and further cooled to 40° F within an additional 4 hours before significant handling/processing begins.”;
  • The firm’s response states that it includes a copy of their entire revised HACCP plan; “However, we have reviewed the HACCP plan you provided, and it continues to fail to identify and list the food safety hazards of Clostridium botulinum and allergens.”
  • The firm did not monitor the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities, protection of food, food packaging material, and food contact surfaces from adulteration and proper labeling, storage and use of toxic chemicals with sufficient frequency to ensure compliance with the current good manufacturing practice requirements as evidenced by observations made by FDA Investigators during their inspection;
  • The FDA has determined that the facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and the FDA implementing regulation at 21 CFR Part 1, Subpart H; “The failure to register a facility as required is a prohibited act.”

Sinu Co.. Ltd — Busan, Korea

A July 24, 2019 Warning Letter to company President Dong Miin Lee noted serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, after inspecting the facility on April 8, 2019.

Additionally, the FDA acknowledged receipt of response from the firm sent via email on April 26, 2019; “Your response included a HACCP plan entitled ‘(Salted Shrimp) Acetes japonicus’ dated April 8, 2019, completed monitoring records, product description, and flow charts.” However, FDA evaluation of the firm’s response revealed it was not adequate.

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. Accordingly, the firm’s refrigerated salted shrimp (intended both to be cooked and as raw ready-to-eat) are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.\

Violations noted by the FDA include:

  • At the time of the inspection, the firm did not have a HACCP plan to control food safety hazards that are reasonably likely to occur for their shrimp; “Your firm provided a HACCP plan dated April 8, 2019 for ‘(Salted Shrimp) Acetes japonicus’ with your April 26th response, however that plan lists critical limits that are not adequate to control pathogen growth.”
  • The flow chart the firm provided with their response indicates that the finished product is frozen; “When using freezing as a strategy to control C. botulinum, FDA recommends, the HACCP plan list a critical control point that requires finished product labeling to state the product is to be kept frozen and thawed under refrigeration.”; and
  • The firm’s finished product label includes handling instructions to “Keep Refrigerated.” However, refrigeration alone is not adequate to control C. botulinum growth and toxin formation.

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