FDA WARNING_LETTER - CJ Dairy Farm - March 11, 2014

On March 4-11, 2014, the FDA inspected CJ Dairy Farm, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The farm offered for sale animals for slaughter as food that were adulterated, specifically two bob veal calves with desfuroylceftiofur residues in kidney tissue (2.1 ppm and 1.67 ppm) exceeding the 0.4 ppm tolerance (21 CFR 556.113), violating 21 U.S.C. 342(a)(2)(C)(ii). Additionally, animals were held under insanitary conditions, including a failure to maintain treatment records, making food adulterated under 21 U.S.C. 342(a)(4). The new animal drug (ceftiofurhydrochloride) was adulterated (21 U.S.C. 351(a)(5)) due to extralabel use not directed by labeling and not under licensed veterinarian supervision (21 CFR 530.11(a)). Furthermore, the dairy cow's medicated colostrum was adulterated (21 U.S.C. 351(a)(6)) by allowing bob veal calves to ingest it, contrary to the drug's approved labeling which prohibits feeding calves milk during treatment. The farm's response was deemed inadequate, lacking proper authority and failing to address all implicated drugs and record-keeping. CJ Dairy Farm must take prompt corrective action, establish preventative procedures, and submit a written response within 15 working days detailing compliance steps and timelines to avoid further regulatory action like seizure or injunction.