FDA WARNING_LETTER - Haldiman, Keith And Patricia - March 11, 2010

On February 1 and March 11, 2010, the FDA inspected Keith and Patricia Haldiman's dairy operation in Hilbert, Wisconsin, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary issue was the sale of an adulterated animal for slaughter. A dairy cow consigned on June 22, 2009, contained sulfamethazine residues (37.280 ppm in liver, 65.57 ppm in muscle) significantly exceeding the 0.1 ppm tolerance (21 CFR 556.670) and phenylbutazone in kidney tissue. Both drugs have no acceptable residue levels in lactating dairy cattle, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act. The investigation also found animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, thus constituting adulteration under section 402(a)(4). Specific deficiencies included failure to maintain complete treatment records (dosage, administration, withholding periods) and a lack of an inventory system for drug quantities. The letter referenced prohibitions on extralabel use of sulfonamides and phenylbutazone in lactating dairy cattle (21 CFR 530.41(a)(9) and (a)(12)). The FDA requires prompt corrective action, establishment of preventative procedures, and a written response within 15 working days detailing actions taken or planned, with documentation. Non-compliance may lead to regulatory actions like seizure or injunction.