Drake Dairy, Inc. – FDA Warning Letter, Feb 14, 2011

An FDA inspection of Drake Dairy, Inc. on January 25 and February 14, 2011, identified significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved offering an adulterated dairy cow for slaughter, which contained ampicillin at 0.33 ppm in kidney tissue, exceeding the 0.01 ppm tolerance (21 CFR 556.40). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act. The investigation also revealed that Drake Dairy held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, constituting adulteration under section 402(a)(4). Specific deficiencies included a lack of an effective system to control drug administration, where herdsmen failed to relay treatment information, and a failure to maintain complete treatment records detailing drug, dosage, route, and withholding periods. The FDA also noted a previous instance of illegal ampicillin and flunixin residues in another dairy cow from the operation in October 2009. Drake Dairy had previously communicated corrective actions, including changes to treatment protocols, record-keeping, and communication systems. However, the FDA requires documentation substantiating these corrections within 15 working days to prevent potential regulatory actions like seizure or injunction. The company is responsible for ensuring overall compliance and food safety.