FDA WARNING_LETTER - Bridgewater Dairy LLC. - December 09, 2013

An FDA inspection of Bridgewater Dairy, L.L.C. on December 3, 6, and 9, 2013, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated dairy cow for slaughter on March 25, 2013. Tissue analysis by USDA/FSIS identified 5.35 ppm of desfuroylceftiofur in the kidney, significantly exceeding the established tolerance of 0.4 ppm (21 C.F.R. 556.113(b)(3)(i)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Further, the operation was found to hold animals under inadequate conditions, such as failing to maintain complete treatment records, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under section 402(a)(4). The firm's veterinary practice also demonstrated improper extralabel drug use of Excenel RTU (ceftiofur hydrochloride) Sterile Suspension (NADA 140-890). This practice did not comply with 21 C.F.R. Part 530, causing the drug to be unsafe and adulterated (sections 512(a)(1) and 501(a)(5)). Specifically, the drug was not used as directed by its approved labeling, and the firm failed to ensure withdrawal periods were met, leading to illegal drug residues (21 C.F.R. 530.20(a)(2)(iv) and 21 C.F.R. 530.11(d)). Bridgewater Dairy is required to take prompt corrective action within fifteen working days, detailing steps to correct violations and prevent recurrence, with supporting documentation. Failure to comply may result in regulatory actions like seizure or injunction.