FDA WARNING_LETTER - Dick-mar Farms

On March 9, 2010, the FDA inspected Dick-Mar Farms, a dairy operation, and identified several violations of the Federal Food, Drug, and Cosmetic Act. The firm offered an adulterated dairy cow for slaughter, which contained violative residues of (b)(4) in its kidney tissue, a new animal drug for which FDA has not established a tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). The investigation also revealed that the farm held animals under insanitary conditions, including a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, violating 21 U.S.C. 342(a)(4). Furthermore, the firm adulterated the new animal drug (b)(4) through extralabel use not directed by approved labeling and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and (c), and causing the drug to be unsafe and adulterated under 21 U.S.C. 360b(a) and 21 U.S.C. 351(a)(5). Finally, Dick-Mar Farms provided a false guaranty to (b)(4) regarding drug residue levels in livestock, a prohibited act under 21 U.S.C. 331(h). The FDA requires prompt corrective action, establishment of preventative procedures, and a written response within fifteen working days detailing steps taken or planned, with documentation, to avoid further regulatory action like seizure or injunction.