FDA WARNING_LETTER - Hometown Veterinary Care, P.C. - January 17, 2014

An FDA investigation conducted on January 14 and 17, 2014, at Hometown Veterinary Care, P.C., owned by Dr. Matthew C. Townsend, revealed significant violations concerning the extralabel use of animal drugs. The firm was found to have caused animal drugs to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), respectively, by failing to comply with the regulations for Extralabel Drug Use in Animals, 21 C.F.R. Part 530. Specifically, the firm prescribed Furosemide Injection 5% for extralabel use in cattle without ensuring the product labeling contained veterinarian-specified directions for use (21 C.F.R. 530.12(c)) or a specified withdrawal time for meat and milk (21 C.F.R. 530.12(e)). Furthermore, the prescription for extralabel use lacked an established substantially extended withdrawal period for edible products, as required by 21 C.F.R. 530.20(a)(2)(ii). The FDA requires prompt corrective action to address these violations and prevent recurrence. A written response detailing corrective steps and timelines must be submitted within fifteen working days. Failure to comply may result in regulatory actions, including seizure and/or injunction.