FDA WARNING_LETTER - Golden Genes Dairy - January 23, 2012

On January 17 and 23, 2012, the FDA inspected Golden Genes Dairy, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary issue involved the sale of an adulterated animal for slaughter, which contained penicillin residues (0.39 ppm in kidney tissue) exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii). The dairy also held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful residues entering the food supply, constituting adulteration under section 402(a)(4). A key deficiency noted was the failure to maintain complete treatment records. Furthermore, the firm adulterated new animal drugs, specifically penicillin G procaine and flunixin meglumine, through improper extralabel use. This included not following approved labeling for penicillin G procaine, not adhering to veterinarian prescriptions for flunixin meglumine, administering penicillin G procaine without licensed veterinarian supervision (21 C.F.R. 530.11(a)), and causing illegal drug residues (21 C.F.R. 530.11(d)). The firm also failed to follow the prescribed route of administration for flunixin meglumine (21 C.F.R. 530.11(a)). These actions caused the drugs to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act. Golden Genes Dairy must take prompt corrective action, establish preventative procedures, and respond to the FDA within fifteen working days, detailing their compliance plan and providing documentation. Failure to comply may lead to regulatory actions like seizure or injunction.