FDA WARNING_LETTER - Butts Dairy Farm - June 21, 2017

The FDA issued a Warning Letter to Charles K. Butts, owner of Butts Dairy Farm, following an investigation on June 19 and 21, 2017, in Cory, Indiana. The investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act, indicating that animals were held under conditions likely to result in medicated animals with harmful drug residues entering the food supply, rendering food adulterated under 21 U.S.C. 342(a)(4). Specific deficiencies included the failure to maintain complete treatment records, an inadequate animal drug inventory system, and the failure to dispose of expired drugs. Furthermore, the firm adulterated the new animal drug (b)(4) by using it extralabelly without following approved labeling or a veterinary prescription, specifically administering incorrect dosages and for an unapproved indication (foot rot instead of bacterial pneumonia), and without consulting a licensed veterinarian, violating 21 C.F.R. Part 530. The firm's July 5, 2017, response to the FDA-483 was deemed inadequate as it lacked evidence of corrective actions, such as updated treatment records or proof of an implemented drug inventory system. Butts Dairy Farm is required to take prompt action to correct all violations and establish preventative procedures. A written response detailing corrective steps and supporting documentation must be submitted to the FDA within fifteen working days to avoid potential regulatory actions like seizure or injunction.