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").
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. All 2014 Warning letters can be accessed here.
Warning Letters issued to dairies
The FDA issued Warning Letters to six dairies 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 insanitary conditions whereby it may have been rendered injurious to health. The recipient dairies were found to have introduced animals with unsafe levels of various drugs present in the animal's tissue into the food supply.
Each dairy was also found to have failed to maintain treatment records for their 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.
Finally, these six dairies were found to have used pharmaceuticals in their cows in a manner not allowed by regulations. One warning letter was issued to a seventh dairy only for violations relating to the extra-label use of animal pharmaceuticals. The extra-label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra-label use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. Most of the dairies were found to have administered drugs to cows without the supervision of a veterinarian.
Warning Letters issued to food-processing facilities
Three food-processing facilities were found by FDA inspectors to have violated the Current Good Manufacturing Procedures (CGMP) for Human Food, Title 21, Code of Federal Regulations, Part 110. The products, which included snack bars, pistachios and cheese, were deemed adulterated. All of these products were deemed adulterated under section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)] 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 pistachio processing facility was found to be the source of an outbreak of salmonella. Employees at the facility were seen touching doors on which bird feces had dried and storage boxes that were resting on the floor prior to touching the product. Observed employees did not wash or sanitize their hands prior to resuming their work of hand-sorting the pistachio product.
The snack food processing facility failed to sanitize machinery in order to prevent contamination by allergens. Additionally, an unknown dark liquid was seen dripping from a central assembly unit into mixing bowls subsequently used for the manufacturing of sesame bars, and food utensils and cutting equipment being stored on a metal rack labeled "clean" were observed to have visible food residue on them after being washed.
Warning Letters issued to seafood processing facilities
Two seafood processing facilities were issued Warning Letters for violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, codified at 21 CFR § 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 FD&C Act, 21 USC. § 342(a)(4). The facilities' HACCP plans lacked required procedures, or, for certain products did not exist at all. Additionally, the facilities failed to properly follow certain procedures listed in their HACCP plan.
Warning Letters issued to shell egg production facilities
The FDA issued Warning Letters to four shell egg processing facilities for violations of the Egg Safety Rule, codified at 21 C.F.R. 118. The FDA found the presence of salmonella enteritidis (SE) in the environmental samples of one of the warned producers. The other three facilities were found not to have properly implemented legally-required measures meant to prevent the same. Additional draft guidance regarding the Egg Safety Rule, meant to provide additional guidelines for compliance with the Rule, was proposed in August 2013.