FDA WARNING_LETTER - Head Farms - August 29, 2013

The FDA conducted an investigation of Head Farm's dairy operation from August 19-29, 2013, finding multiple violations of the Federal Food, Drug, and Cosmetic Act. On January 2, 2013, Head Farm sold a bob veal calf for slaughter, which, upon USDA/FSIS analysis, contained sulfamethoxazole in kidney tissue. FDA has no tolerance for this drug in veal, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, specifically inadequate record-keeping for medicated animals. Treatment records lacked indication for use, route, dosage frequency, duration, and meat withdrawal times, making food from such animals adulterated under section 402(a)(4).

Furthermore, Head Farm adulterated the human drug (b)(4) by using it extralabelly without veterinarian supervision and failing to observe the directed withdrawal period for a bob veal calf. This violated 21 C.F.R. 530.11(a) and (c), causing the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act.

Head Farm's September 1, 2013, response acknowledging observations lacked specific actions or implementation dates. The FDA requires a