The 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”).
Below is a brief synopsis of FDA’s food-related Warning Letters issued and posted between February 14, 2014 and March 14, 2014.
Warning Letters issued to dairies, veterinarians and animal dealers
FDA issued Warning Letters to five dairies that sold adulterated animals for slaughter as food: Erickson Dairy, LLC in Neillsville, WI; Falls View Farm in Richfield Springs, NY; Bridgewater Dairy, LLC in Montpelier, OH; Reyskens Dairy, LLC in Custer, OH; and the farm of Alex and Wayne Jackson in Union, ME.
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 unsanitary conditions. Failure to maintain complete treatment records presumes the food to be held under unsanitary 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.
In addition, it was found that the five dairies mentioned above also 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 four of the dairies: the Erickson Dairy, LLC, Falls View Farm, Reyskens Dairy, LLC and Alex and Wayne Jackson’s farm. Even though at the Bridgewater Dairy, LLC the extra-label use was prescribed by a vet, it did not meet the necessary withdrawal timeframes and, as a result, illegal drug residues were present.
Further, FDA issued a Warning Letter to Hometown Veterinary Care, PC in Fairfield ME, for the unsafe and adulterated use of drugs. Specifically, this veterinary practice failed to properly label medicine with the directions for use and with the necessary withdrawal period prior to marketing the meat and milk specified by the veterinarian.
FDA also issued a Warning Letter to an animal dealer, Wilton Black in Litchfield, ME, who sold adulterated animals for slaughter as food. Dealers of animals frequently introduce, or offer, adulterated animals for introduction into interstate commerce. Accordingly, dealers share the responsibility for violating the Federal FDCA. To avoid illegal residue violations for animal dealers, the FDA recommended for the dealer to 1) implement an identification system that establishes traceability to the source of the purchased animal, 2) implement a system to determine whether the animal has been medicated and with what drug(s) from the purchased animal’s source, and 3) if the animal has been medicated, to implement a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue.
Warning Letters issued to seafood processing facilities
FDA issued Warning Letters to two seafood processing facilities for selling adulterated products under the seafood Hazard Analysis and Critical Control Point (HACCP) regulation: Pulmuone Foods USA, Inc. in Fullerton, CA and 17 Merrill Drive, LLC in Rockland, ME.
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 these two facilities were deemed adulterated because both failed to properly document, implement, and monitor their respective HACCP plans. Further, 17 Merrill Drive LLC violated Current Good Manufacturing Procedures (CGMP) for Human Food, 21 C.F.R. 110, because it 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. FDA found issues with steam condensation generated by the cooking process that was dripping from the ceiling into the raw area due to inadequate exhaust/ventilation; discolored and rusty ice chute; and cleaning hoses in direct contact with wet processing room floors in the raw and high risk areas when not in use.
Warning Letters issued to food processing facilities
FDA issued a Warning Letter to a food processing facility, Bluegrass Holdco, Inc. in Stamford, CT, for manufacturing adulterated food products and violating the CPMG for Human Food.
Investigators identified the presence of salmonella at the Bluegrass Holdco, Inc. and determined that the food products processed at this whey powder manufacturing facility 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.”
The FDA noted that this was a repeated salmonella finding at this facility. While Bluegrass Holdco, Inc. had offered in its response that it had shut down and was thoroughly cleaning the facility, and had hired a third-party consultant to investigate the contamination problem, FDA replied that the response lacked further detail about the specific corrective actions the facility has taken or will take, and the explanation of their appropriateness.
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.
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