Davis Farm – FDA Warning Letter, Jun 29, 2011

An FDA inspection of Davis Farm, a dairy operation in Berkshire, New York, conducted on June 27 and 29, 2011, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated bob veal calf for slaughter, whose tissue samples contained illegal levels of sulfamethazine (19.134 ppm in liver, 27.784 ppm in muscle), exceeding established tolerances for bob veal. This rendered the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). Further, the farm was found to hold animals under inadequate conditions, such as failing to maintain treatment records and properly identify or segregate treated animals, increasing the likelihood of medicated animals with harmful drug residues entering the food supply. This constitutes adulterated food under 21 U.S.C. § 342(a)(4). The new animal drug (b)(4) was also found to be adulterated due to extralabel use. Specifically, sulfamethazine was administered to a bob veal calf contrary to its approved labeling regarding animal class. This extralabel use was not supervised by a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in illegal drug residues, violating 21 C.F.R. 530.11(c). Consequently, the drug was deemed unsafe and adulterated under 21 U.S.C. § 360b(a) and § 351(a)(5). Davis Farm is required to take prompt corrective actions and establish procedures to prevent recurrence. A written response detailing these steps, including documentation and timelines, must be submitted to the FDA within fifteen working days. Failure to comply may lead to regulatory actions like seizure or injunction.