FDA WARNING_LETTER - Horizon Acres - December 20, 2010

On November 10, 12, 19, 24, and December 20, 2010, the FDA inspected Horizon Acres' veal calf operation in Dalton, Ohio, and found significant violations. The firm offered for sale an adulterated veal calf for slaughter, which contained 0.28 ppm of flunixin in liver tissue, exceeding the 0.125 ppm tolerance and having no acceptable level for veal calves, violating 21 U.S.C. § 342(a)(2)(C)(ii). Additionally, animals were held under insanitary conditions, including a failure to maintain complete treatment records and segregate treated animals, leading to potential drug residues in the food supply, violating 21 U.S.C. § 342(a)(4).

The firm also adulterated several new animal drugs (Suppressor, Dexamethasone, Ceftiflex, PennOne Pro, Amoxicillin, SMZ-TMP, Pennchlor 64) by using them extralabel without following approved labeling, often without licensed veterinarian supervision, and sometimes resulting in illegal residues or improper administration/duration/route, violating 21 C.F.R. § 530.11(a), (b), and (c). Furthermore, liquid animal feed was adulterated by adding sulfamethoxazole and trimethoprim, Amoxicillin, and chlortetracycline HCI, and failing to use the medicated feed in conformance with its approved labeling, violating 21 U.S.C. § 351(a)(6). Horizon Acres must take prompt corrective action within fifteen working days to prevent recurrence, or face regulatory actions like seizure or injunction.