FDA WARNING_LETTER - Cache Creek Dairy - February 10, 2011

The FDA conducted an inspection of Cache Creek Dairy in Woodland, California, on February 1, 2, and 10, 2011, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated dairy cow for slaughter. Tissue analysis revealed sulfadimethoxine residues at 0.431 ppm in the liver, exceeding the established tolerance of 0.1 ppm (21 C.F.R. 556.640), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

Furthermore, the dairy held animals under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, constituting adulteration under 21 U.S.C. § 342(a)(4). A specific deficiency noted was the failure to maintain complete treatment records.

The inspection also uncovered multiple instances of illegal extralabel drug use. Sulfadimethoxine was administered to a dairy cow without adhering to the approved dose and route, and its extralabel use is prohibited in lactating dairy cattle (21 C.F.R. 530.41(a)(9)), leading to an illegal drug residue (21 C.F.R. 530.11(d)). Flunixin meglumine was administered without following the approved route and lacked supervision by a licensed veterinarian (21 C.F.R. 530.11(a)). These extralabel uses caused the drugs to be unsafe and adulterated under 21 U.S.C. §§ 360b(a) and 351(a)(5).

Cache Creek Dairy is required to take prompt corrective actions and submit a written response within fifteen working days, detailing steps to correct and prevent recurrence of these violations. Failure to comply may lead to further regulatory actions, including seizure or injunction.