FDA WARNING_LETTER - Crossbrook Farm - May 15, 2014

The FDA conducted an investigation of Crossbrook Farm on March 25, April 10, and May 15, 2014, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The farm offered for sale a dairy cow for slaughter that was adulterated, containing penicillin residues (0.084 ppm) in kidney tissue, exceeding the established tolerance of 0.05 ppm (21 C.F.R. 556.510), violating 21 U.S.C. § 342(a)(2)(C)(ii). Furthermore, the farm held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, constituting adulteration under 21 U.S.C. § 342(a)(4), exemplified by a failure to maintain complete treatment records. The new animal drug Penicillin G Procaine Injectable Suspension was also found to be adulterated (21 U.S.C. § 351(a)(5)) due to extralabel use not directed by its approved labeling. Specifically, this extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)) and resulted in illegal drug residue (21 C.F.R. 530.11(d)), rendering the drug unsafe (21 U.S.C. § 360b(a)). Crossbrook Farm is required to take prompt corrective action and establish preventative procedures, responding to the FDA within fifteen working days. Failure to comply may lead to regulatory actions like seizure or injunction.