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 ("the FD&C Act"). Below is a brief synopsis of recent food-related Warning Letters.
The FDA issued Warning Letters to one dairy for selling animals for slaughter that were adulterated. Under 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 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 FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under unsanitary conditions whereby it may have been rendered injurious to health. The recipient dairy was found to have introduced into the food supply animals with unsafe levels of sulfamethazine (a medication that treats bacterial diseases) present in the animal's tissue. The dairy was also found to generally hold its animals under conditions that were inadequately monitored. For example, the dairy failed to maintain treatment records for its cows. The FDA asserted that this inadequate monitoring caused it to be more likely that medicated animals bearing potentially harmful drug residues would enter the food supply.
A food processing facility that manufactures "ready-to-eat salad" was warned that FDA analysis of environmental swabs showed the presence of Listeria monocytogenes, a human pathogen, at the facility. The pathogen was found to be present, in part, due to the dripping of condensate from a metal water line into a mayonnaise mixing vat. In addition, FDA investigators observed violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulations, Title 21 Code of Federal Regulations, Part 110 (21 CFR Part 110), including the plant's failure to prevent condensate from contaminating food and food-contact surfaces.
Another food processing facility was found to have adulterated mung bean, clover, alfalfa, and radish sprouts. Sprout trays, utensils, and processing equipment were not washed or sanitized, but merely rinsed. Additionally some trays had visible sprout residue. The tank used to hold and distribute irrigation water for the facility's ready-to-eat sprout growing process was also corroded with visible flaking rust. The FDA provided information on proper handling and controls for sprout manufacturing, referencing the agency's Guidance for Industry.
Two seafood processing facilities were issued Warning Letters for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, codified in 21 C.F.R. 123. Because these facilities failed to properly implement their HACCP plans, their seafood products were rendered adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC. § 342(a)(4). The facilities' HACCP plans lacked required procedure, or, for certain products, did not exist at all. Additionally, the facilities failed to properly follow certain procedures listed in their HACCP plan.
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.