It is FDA’s practice to issue Warning Letters in order to provide individuals and companies an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The agency’s position is that it issues Warning Letters only for violations of regulatory significance.  Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency’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 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 recent food-related Warning Letters issued between September 5th and October 17th.

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 that these dairies failed to maintain complete animal treatment records.

It also found that all three dairies held animals under conditions that were so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply.

Warning Letters issued to two livestock operations
FDA issued Warning Letters to two livestock operations 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 USDA/FSIS examined tissue samples from the recipient operations and found drug residue at both.  These findings showed that the samples exceeded FDA’s acceptable drug residue levels and that these livestock operations failed to maintain complete animal treatment records.

The investigation also revealed that one of the livestock operations provided a false guaranty when it claimed it did not market livestock with an illegal drug residue.

Warning Letters issued to five seafood processing facilities
FDA issued Warning Letters to five 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.”

Seafood products at all five facilities were deemed adulterated because the facilities did not perform affirmative steps to ensure its products were processed in accordance with safety regulations. Specific violations included: (1) failure to properly monitor temperatures of seafood products; (2) failure to cover seafood products in ice during transport; (3) failure to monitor sanitation conditions; and (4) failure to ensure product labels identified fish by the market name of the specific species.

Warning Letters issued to four food processing facilities
FDA issued Warning Letters to four food processing facilities, for manufacturing adulterated food products in violation of the Current Good Manufacturing Procedures (CGMP) for Human Food because they failed to monitor the following:  (1) the cleanliness of food contact surfaces; (2) the prevention of cross-contamination from insanitary objects; and (3) the protection of food contact surfaces from adulteration with chemical, physical, and biological contamination.

FDA inspections revealed that three of the facilities prepared, packaged, or held food under insanitary conditions whereby products could have become contaminated with filth or could have been rendered injurious to health.

It was also revealed that products at one of the facilities were misbranded within the meaning of the FDCA in that they failed to declare the presence of major food allergens in the products, namely milk, and to include a complete list of all the ingredients by common or usual name.

The same facility was cited for failing to submit a report to the Reportable Food Registry after it determined that one of its products contained an undeclared food product that caused at least one consumer to have an allergic reaction.

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