FDA WARNING_LETTER - Harris Dairies - March 19, 2008

The FDA issued a Warning Letter to Harris Dairies following an inspection from March 17-19, 2008, which confirmed the sale of an adulterated Holstein dairy cow on December 7, 2007. Tissue samples from the slaughtered animal revealed sulfadimethoxine at 0.13 ppm in the liver, exceeding the 0.1 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The inspection also found that Harris Dairies holds animals under inadequate conditions, making it likely that medicated animals with harmful drug residues enter the food supply, violating 21 U.S.C. § 342(a)(4). Specifically, the firm lacked an adequate system to ensure appropriate withdrawal times for medicated animals, including incomplete treatment records. Furthermore, the firm adulterated sulfadimethoxine soluble powder by using it extralabel, not in conformance with its approved labeling, which is prohibited in lactating dairy cows (21 C.F.R. 530.41(a)(9)) and resulted in illegal drug residues (21 C.F.R. 530.11(d)). This extralabel use rendered the drug unsafe and adulterated under 21 U.S.C. § 351(a)(5) and § 360b(a). Harris Dairies must promptly correct these violations and establish preventative procedures. A written response detailing corrective actions and timelines is required within fifteen working days to avoid further regulatory action like seizure or injunction.