The Food and Drug Administration (“FDA”) issues Warning Letters to provide individuals and companies with an opportunity to take voluntary and prompt corrective actions for violations of regulatory significance that may otherwise lead to enforcement. A Warning Letter is the FDA’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (FDCA).

Companies in receipt of a Warning Letter have 15 days to respond to the agency, in writing, to explain the steps taken to correct the violations. The FDA then evaluates the responses and, if needed, can take regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures.

Below is a brief synopsis of FDA’s food-related Warning Letters issued and posted between April 8, 2014 and May 17, 2014.

Warning Letters issued to three dairies

FDA issued Warning Letters to three dairies that sold adulterated animals for slaughter as food. Such food is deemed to be adulterated if 1) it bears or contains a new animal drug that is unsafe, and/or 2) the animal has been held under insanitary conditions. Failure to maintain complete treatment records presumes the food to be held under insanitary conditions.

The United States Department of Agriculture, Food Safety and Inspection Services (USDA/FSIS) examined tissue samples from the recipient dairies and found drug residue at each. These findings showed that the samples exceeded FDA’s acceptable drug residue levels and these dairies failed to maintain complete animal treatment records.

It was also found that all three farms used drugs off-label. The off-label use of approved animal or human drugs in animals is allowed only if a licensed veterinarian within the context of a valid veterinarian-client/patient relationship prescribes it. Further, appropriate measures must be taken to assure that assigned timeframes for withdrawal before marketing are met and no illegal drug residues occur in any food-producing animal subjected to the extra-label use. However, no record of supervision by a licensed veterinarian was found at any of the dairies.

Warning Letters issued to seafood processing facilities

FDA issued Warning Letters to seven seafood processing facilities for selling adulterated products under the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

Under the HACCP regulation, a seafood processing facility must have an annually signed and dated HACCP plan. The HACCP plan must contain the appropriate “critical limits”, which are measured and verified. These would include, for example, temperature control measures that are monitored with calibrated instruments, and a list of the food safety hazards of pathogens caused by time and temperature abuse, and undeclared allergens. A food safety hazard is defined as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.”  Moreover, any importer of seafood must have a written import verification procedure to ensure the imported fish and fishery products were processed in accordance with US standards.

Imported seafood products at two of these fisheries were deemed adulterated because the facilities did not perform an affirmative step to ensure its products were processed in accordance with the US standards. The FDA collected samples from one of these fisheries that revealed products were uneviscerated and contained salmonella.

Products from four of the facilities were deemed adulterated because they failed to properly correct, document, implement, and monitor their respective HACCP plans after their initial Warning Letters from the FDA. The FDA warned that if not cured within 15 days, the agency may take further action such as to seize products and/or enjoin each firm from operating.

Products from two of the facilities were also misbranded. Under the FDCA, seafood product labels must declare the common name or an acceptable market name for any fish including salmon in the United States. Further, under the FDCA, labels of fabricated products must declare all ingredients on the label, including, for example, brine pre-mixtures. The two facilities failed to properly label their products.

Warning Letters issued to food processing facilities

FDA issued Warning Letters to four food processing facilities, for manufacturing adulterated food products in violation of the Current Good Manufacturing Practices (CGMP) for Human Food because they failed to monitor:  the cleanliness of food contact surfaces, the prevention of cross-contamination from insanitary objects, and the protection of food contact surfaces from adulteration with chemical, physical, and biological contamination.

At one of the facilities, investigators identified the presence of pathogenic bacteria and determined the food products processed there were adulterated in that they have been “prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health.” Rodent excreta pellets and uncovered containers of rodent poison were found in another.

At three of the facilities, products were also misbranded within the meaning of the FDCA, failing to declare a major allergen and to declare all of the ingredients included in fabricating the product.

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