FDA WARNING_LETTER - Brockway Hilltop Farms LLC - April 10, 2013

An FDA inspection of Brockway Hilltop Farms LLC, a dairy operation, conducted in March and April 2013, revealed multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale two bob veal calves for slaughter that were adulterated, containing illegal drug residues. Tissue samples from a calf sold on September 27, 2012, showed desfuroylceftiofur at 3.25 ppm (tolerance 0.4 ppm) and Dexamethasone (no tolerance) in kidney tissue. A calf sold on October 3, 2012, similarly contained desfuroylceftiofur at 1.21 ppm and Dexamethasone. These findings violate FD&C Act section 402(a)(2)(C)(ii).

The investigation also found that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful residues entering the food supply, violating FD&C Act section 402(a)(4). Specifically, the firm failed to maintain treatment records. Furthermore, the new animal drugs (b)(4) (ceftiofur sodium) and Dexamethasone Solution were adulterated and used extralabelly without veterinary supervision, violating 21 C.F.R. 530.11(a). This extralabel use resulted in illegal drug residues, violating 21 C.F.R. 530.11(d) and 530.11(c), rendering the drugs unsafe and adulterated under FD&C Act sections 512(a) and 501(a)(5). The firm must take prompt corrective action, including establishing recurrence prevention procedures, and respond to the FDA within 15 working days with detailed plans and documentation, or face potential regulatory action such as seizure or injunction.