FDA WARNING_LETTER - A&M; Farms - January 05, 2012

On January 4 and 5, 2012, the FDA inspected A&M Farms in Fresno, California, and found violations of the Federal Food, Drug, and Cosmetic Act. A cow consigned for slaughter on September 30, 2011, was found to have penicillin at 0.12 ppm in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, indicating that medicated animals with harmful drug residues are likely to enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, A&M Farms adulterated the new animal drug (b)(4) brand (b)(4) (penicillin G procaine) Injectable Suspension by using it extralabel without following approved dosage amounts and per-injection site guidelines. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(d). This caused the drug to be unsafe and adulterated under 21 U.