FDA WARNING_LETTER - John Bootsma Dairy - August 30, 2011

On August 1, 8, and 30, 2011, the FDA investigated John Bootsma Dairy, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on May 4, 2011, had flunixin in its liver tissue at 0.174 ppm, exceeding the 0.125 ppm tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The dairy also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating 21 U.S.C. 342(a)(4). This was evidenced by a failure to maintain complete treatment records.

Furthermore, the dairy engaged in extralabel drug use without veterinary supervision, violating 21 C.F.R. 530.11(a) and 530.11(d). This included administering Flunixin Meglumine without observing withdrawal periods, resulting in illegal residues. Other drugs, such as Penicillin G Procaine, Pirlimycin Hydrochloride, Ceftiofur Sodium, Ceftiofur Hydrochloride, and Dexamethasone, were used extralabelly without following approved labeling for dose, route, duration, frequency, or withdrawal times, causing these drugs to be unsafe and