FDA WARNING_LETTER - Peyerk Brothers Dairy LLC - June 28, 2013

On August 15, 2013, the FDA issued a Warning Letter to Peyerk Brothers Dairy LLC following an investigation on June 19 and 28, 2013, at their Harbor Beach, Michigan dairy operation. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on October 16, 2012, Peyerk Brothers Dairy sold a dairy cow for slaughter that was found to have desfuroylceftiofur in its kidney at 6.92 ppm, exceeding the FDA tolerance of 0.4 ppm. This rendered the animal's meat adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. The FDA also found that the dairy's conditions were insanitary, with inadequate record-keeping for medicated animals, increasing the likelihood of harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4).

Furthermore, the dairy adulterated new animal drugs, Excede and Vetrimycin, by using them extralabelly without veterinary supervision. Excede was administered without following withdrawal periods or indications, resulting in illegal drug residues. Vetrimycin was administered via an unapproved route. These extralabel uses violated 21 C.F.R. 530.11(a) and (d), causing the