FDA WARNING_LETTER - Roest Family Dairy - April 17, 2013

The FDA conducted an investigation of Roest Family Dairy in Modesto, California, on April 4, 10, 12, and 17, 2013, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The dairy was found to have adulterated new animal drugs, specifically sulfamethazine sustained release bolus, oxytetracycline hydrochloride injection, and flunixin meglumine injectable solution. The primary deficiency was the extralabel use of these drugs, meaning they were not used as directed by their approved labeling or veterinarian's prescriptions, violating 21 C.F.R. 530.3(a) and other sections of 21 C.F.R. Part 530.

Specific violations included administering sulfamethazine to a lactating dairy cow, which is prohibited for extralabel use in this animal class by 21 C.F.R. 530.41(a)(9). Oxytetracycline was administered to lactating dairy cows without following the approved animal class and, critically, without the supervision of a licensed veterinarian, a violation of 21 C.F.R. 530.11(a). Similarly, flunixin meglumine was given to lactating dairy cows without adhering to the prescribed dose and route of administration, and also without licensed veterinary supervision, again violating 21 C.F.R. 530.11(a). These actions rendered the drugs unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act. The FDA requires prompt corrective action and a written response within fifteen working days detailing steps taken to correct violations and prevent recurrence, warning of potential regulatory actions like seizure or injunction if compliance is not achieved.