FDA WARNING_LETTER - Hawk Dairy Farm - November 03, 2015

On September 8, 9, and November 3, 2015, the FDA inspected Hawk Dairy Farm in Minerva, Ohio, and identified significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved offering for sale an adulterated dairy cow for slaughter. Tissue samples from this animal, sold on March 2, 2015, revealed penicillin residues of 0.363 ppm in the kidney, significantly exceeding the FDA tolerance of 0.05 ppm established in 21 C.F.R. 556.510(a). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the investigation found that the farm holds animals under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, violating section 402(a)(4) of the FD&C Act. Specific deficiencies contributing to these conditions included a failure to maintain complete treatment records and the lack of an adequate drug inventory system. The FDA emphasized that these are not exhaustive violations and that the farm is responsible for overall compliance. Hawk Dairy Farm must take prompt corrective action and establish preventative procedures. A written response detailing these steps, including timelines and documentation, is required within fifteen working days to avoid potential regulatory actions like seizure or injunction.