FDA WARNING_LETTER - Wright Family Dairy - July 01, 2010

On June 29 and July 1, 2010, the FDA inspected Wright Family Dairy, Baxley, Georgia, finding violations of the Federal Food, Drug, and Cosmetic Act. The dairy sold two cows for slaughter on January 25 and February 15, 2010, which were found to have flunixin residues in liver tissue exceeding the 0.125 ppm tolerance (0.151 ppm and 0.512 ppm respectively). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the dairy held animals under insanitary conditions, failing to maintain complete treatment records, specifically lacking drug amount, route of administration, and withdrawal times, leading to adulterated food under section 402(a)(4). The new animal drug flunixin meglumine was also adulterated under section 501(a)(5) because it was used extralabelly without proper veterinary supervision, violating 21 C.F.R. 530.11(a) and resulting in illegal drug residues, violating 21 C.F.R. 530.11(d). Specifically, withdrawal times and prescribed doses were not followed.

The FDA acknowledged the dairy's July 1, 2010, response but deemed it lacking sufficient detail