The Food and Drug Administration recently sent warning letters to a hard boiled egg processor in Gainesville, GA, and a seafood processor in Clare, Ireland, 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.

Almark Foods Inc. — Gainesville, GA

Almark Foods Inc.’s hard boiled egg processing facility in Gainesville, GA, was inspected by the FDA from Feb. 5 through 13, and the results determined that the firm’s food products are adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Specifically, lab tests showed the plant was harboring the pathogen Listeria monocytogenes, and the FDA noted significant violations of the CGMP & PC Rule.

“L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment.  Without proper controls, it can proliferate in food processing facilities where it may contaminate food.

”Therefore, it is essential to identify the areas of the food processing plant where this organism can grow and survive and take such corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions,” the FDA warned.

According to the warning letter, Whole Genome Sequencing analysis of an environmental sample collected on Feb. 6, confirmed that two environmental swabs were positive for L. monocytogenes.

“One environmental swab was collected from a peeling room floor drain,” and, “One environmental swab was collected from the egg counter entrance and stainless-steel area at the end of the conveyor belt,” which is a food contact surface.

FDA officials encouraged the firm to review FDA’s draft guidance for industry entitled, “Control of Listeria monocytogenes in Ready-To-Eat Foods” for assistance in developing a Listeria control plan to help the firm comply with the CGMP and PCHF requirements.

The FDA noted a submitted written response from the firm, regarding the L. monocytogenes findings; “We are aware that you have recalled products and initiated a study,” however the FDA noted they, “will verify the implementation of your corrective actions and their adequacy during the next FDA inspection.”

The following were among Almark Foods Inc.’s violations of the CGMP & PC Rule:

  • The firm’s hazard analysis did not identify environmental pathogens, such as L. monocytogenes, as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control;
  • The firm’s hazard analysis did not identify the microbiological hazard of Clostridium botulinum (i.e., growth and/or toxin formation due to reduced oxygen packaging) as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control at the finished product storage step; and
  • On Feb. 5 and 6, FDA investigators observed buckets of salad eggs being stored unattended at ambient temperatures in the peeling room for at least three hours each day; “We recommend that you monitor the length of time in which these work-in-process eggs are subjected to ambient temperatures, such as those you indicate for your peeling room, to avoid the potential growth of pathogens.”

Additionally, after the FDA’s inspection, the firm provided a preservative study intended to show the use of a preservative for “elimination of pathogens in an (undisclosed) time period.” The FDA noted that this study is not adequate to validate the use of this treatment on eggs to eliminate pathogens because it does not address use of the treatment under the firm’s processing conditions.

Because the firm utilizes thermometers to obtain the internal temperatures of hard-cooked eggs with temperatures closer to the boiling point than near refrigeration temperatures, the FDA suggested that the firm calibrate using the boiling water method by immersing the probe into boiling water (212°F).

The FDA reminded the firm to include the timeframes in which their corrections will be completed and provide any documentation that will assist the FDA in evaluating whether the corrective actions have been made, in their response.

Burren Smokehouse Ltd. — Clare, Ireland

In a warning letter dated July 30, 2019, the FDA informed Managing Director Birgitta Hedin Curin that Burren Smokehouse Ltd.’s hot and cold smoked salmon, trout, and mackerel products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.

Furthermore, FDA inspectors found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) play for their refrigerated, vacuum-packaged hot and cold smoked fish products, flow charts, and an SOP for cleaning the vacuum packaging machine.

The FDA acknowledged a receipt of the firm’s email response, received in the FDA office on March 21, April 2 and 29 to the deviations observed during March inspections and evaluated their response of corrective actions relative to the following violations:

  • The firm’s HACCP plans provided with their responses do not list one or more critical control points to control the food safety hazard of pathogen growth and toxin formation; “which is not included as a critical control point needs to be listed as an actual critical control point to control the hazard of C. botulinum growth and toxin formation in the vacuum-packaged finished product and pathogen growth and toxin formation during salting.”;
  • The firm must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point;
  • Upon further review of the firm’s revised HACCP plans, FDA recommends the firm update their critical limits at refrigerated storage and in-process handling to ensure the products are held at or below 4.4°C (40°F) or less, rather than 5° C;
  • The firm’s critical limits need to address finished product labeling;
  • FDA recommends a critical control point for finished product labeling with a critical limit that lists all finished product labeling must accurately declare all major food allergens that are included in the product formulation; and
  • In addition, the firm’s HACCP plan for their hot smoked farmed trout does not identify the hazard allergens.

“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 plans, five 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 plans, 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,” the FDA added.

Additionally, “If you do not respond or if we find your response inadequate, we may take further action,” the FDA warned.

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