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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. 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 published between December 14th and January 18th.

Warning Letters issued to four dairies

FDA issued Warning Letters to four dairies for selling animals for slaughter that were adulterated. Under 402(a)(2)(C)(ii) of the FDCA, 21 USC. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FDCA, 21 USC. § 360b. Further, under section 402(a)(4) of the FDCA, 21 USC. § 342(a)(4), a food is deemed adulterated if it has been held under unsanitary conditions whereby it may have been rendered injurious to health.

The recipient dairies were found to have introduced into the food supply animals with unsafe levels of various drugs, including ampicillin, sulfadimethoxine, and neomycin, present in the animal’s tissue.

Investigations also revealed that the facilities improperly administered human or animal drugs to livestock by, for example, not following the dose stated in the approved label. The FDCA allows extralabel use of approved animal and human drugs in animals if the extralabel use complies with certain regulations, including that extralabel uses are by or on the order of a licensed veterinarian within the context of a veterinarian/client/patient relationship. These facilities were found to improperly administer drugs to animals without the required veterinary supervision.

Warning Letters issued to one seafood processing facility

FDA issued Warning Letters to one seafood processing facility 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.”

The facility’s violations included:

  1. failure to have a HACCP plan for all products;
  2. failure to set temperatures in the HACCP plan that are sufficient to prevent pathogenic bacteria grown or toxin formation;
  3. failure to include critical limits for brining or cooling in the facility’s HACCP plan; and
  4. failure to monitor the safety of water that comes into contact with food or food contact surfaces.

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