FDA WARNING_LETTER - Hill, Brian & Barbara - March 24, 2010

On March 24, 2010, an FDA investigation of Brian & Barbara Hill's dairy operation in Maple Park, Illinois, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The primary issue was the sale of an adulterated dairy cow for slaughter, which contained 2.649 ppm of sulfamethazine residue in its liver, far exceeding the 0.1 ppm tolerance (21 C.F.R. 556.670), rendering the food adulterated under Section 402(a)(2)(C)(ii) of the Act. Further deficiencies included holding animals under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under Section 402(a)(4). Specifically, the firm failed to maintain treatment records. The FDA also found that the new animal drug sulfamethazine boluses were adulterated due to extralabel use not directed by approved labeling. This extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)) and resulted in an illegal drug residue (21 C.F.R. 530.11(d)). Consequently, the drug itself was deemed unsafe (Section 512(a)) and adulterated (Section 501(a)(5)). The letter mandates prompt corrective actions within fifteen working days, including establishing procedures to prevent recurrence. Failure to comply may lead to regulatory actions such as seizure or injunction, emphasizing the need for the operation to ensure full compliance with food safety laws.