FDA WARNING_LETTER - Busman Dairy - March 30, 2010

On March 25 and 30, 2010, the FDA investigated a dairy operation at 2304 East 3200 South, Jerome, Idaho, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated cow for slaughter on December 22, 2009. USDA/FSIS analysis of tissue samples from this animal, slaughtered on December 24, 2009, revealed 0.62 ppm of sulfamethazine in the liver, exceeding the FDA tolerance of 0.1 ppm (21 C.F.R. 556.670). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the investigation found insanitary conditions, specifically inadequate record-keeping for animal treatments and a lack of an adequate drug inventory system, making it likely that medicated animals with harmful drug residues could enter the food supply. This constitutes adulteration under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

The FDA requires prompt corrective action to address these violations and prevent recurrence. Failure to comply may result in regulatory actions