Hunter Haven Farms – FDA Warning Letter, May 24, 2011

On May 11 and May 24, 2011, the FDA inspected Hunter Haven Farms, Inc., identifying violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on January 26, 2011, was found to have penicillin at 0.33 ppm in kidney tissue, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510), rendering the food adulterated under Section 402(a)(2)(C)(ii) of the FD&C Act.

The farm also held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under Section 402(a)(4) of the FD&C Act. Furthermore, the farm engaged in extralabel use of penicillin without following approved labeling withdrawal periods, resulting in illegal drug residues and violating 21 CFR 530.11(d). This non-conformance caused the drug to be unsafe under Section 512(a) and adulterated under Section 501(a)(5) of the FD&C Act.

Hunter Haven Farms must take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and timelines is required within fifteen working days to the FDA