FDA WARNING_LETTER - Barrington Dairy Farm - December 05, 2014

On December 3-5, 2014, the FDA inspected Barrington Dairy, Live Oak, Florida, identifying violations of the Federal Food, Drug, and Cosmetic Act. The dairy sold two adulterated cows for slaughter. A cow sold on March 15, 2014, had desfuroylceftiofur (ceftiofur marker) at 3.52 ppm in kidney tissue, exceeding the 0.4 ppm tolerance. Another cow sold on May 27, 2014, had 3.67 ppm. These levels caused the food to be adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, making food adulterated under 21 U.S.C. § 342(a)(4). Furthermore, the dairy adulterated new animal drugs Naxcel and Excenel RTU EZ by using them extralabelly without veterinary supervision, violating 21 C.F.R. § 530.11(a), and resulting in illegal residues, violating 21 C.F.R. § 530.11(d). Prohibited extralabel use of cephalosporins (Excenel RTU EZ and Naxcel) by unapproved routes and doses also