FDA WARNING_LETTER - Hostetler, Atlee W. - January 15, 2010

An FDA investigation conducted on January 11 and 15, 2010, at Atlee W. Hostetler's dairy operation in Apple Creek, Ohio, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated bull calf for slaughter. Specifically, a bull calf sold on August 19, 2009, contained unsafe residues of sulfamethoxazole (0.876 ppm in muscle, 0.465 ppm in liver), for which FDA has no established tolerance, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act. The investigation also found that animals were held under insanitary conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, constituting adulteration under section 402(a)(4). This was evidenced by a failure to maintain treatment records and an inadequate drug inventory system. Furthermore, the firm adulterated new animal drugs by using Sulfamethoxazole and Trimethoprim Tablets, USP, in an extralabel manner, not as directed by approved labeling. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in illegal drug residues, violating 21 C.F.R. 530.11(c). These actions caused the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the Act, respectively. The FDA requires prompt corrective action and a written response within fifteen working days detailing steps taken to correct violations and prevent recurrence.