FDA WARNING_LETTER - H & D Farms - March 28, 2013

On March 18, 19, 21, and 28, 2013, the FDA inspected H & D Farms, a dairy operation. The inspection revealed several violations of the Federal Food, Drug, and Cosmetic Act.

A dairy cow sold for slaughter on August 15, 2012, was found to have penicillin at 0.19 ppm in its kidney, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). The farm also failed to maintain complete treatment records, indicating insanitary conditions where medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).

Furthermore, the new animal drug AGRI-CILLIN (penicillin) was adulterated because it was used extralabelly without veterinary supervision, violating 21 C.F.R. 530.11(a) and making the drug unsafe under 21 U.S.C. 360b(a) and adulterated under 21 U.S.C. 351(a)(5). The farm also provided a false "LIVESTOCK OWNERS' CERTIFICATE" on May 11, 200