Dean and Jean Mikalunas – FDA Warning Letter, Apr 21, 2014

On April 9 and 21, 2014, the FDA inspected Dean and Jean Mikalunas Farm in Sherburne, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act related to the extralabel use of the new animal drug ceftiofur sodium sterile powder (ANADA (b)(4)).

Specifically, the farm administered this drug to dairy cows without adhering to the four-day slaughter withdrawal time stated on the approved labeling. This constituted an extralabel use not directed by the approved labeling or a servicing veterinarian's prescription, violating 21 CFR 530.3(a). Furthermore, this extralabel use was not under the supervision of a licensed veterinarian, violating 21 CFR 530.11(a).

These actions caused the drug to be unsafe under section 512(a) of the FD&C Act (21 U.S.C. 360b(a)) and adulterated under section 501(a)(5) of the FD&C Act (21 U.S.C. 351(a)(5)). The FDA emphasized that the farm is responsible for ensuring compliance with the law for its operations and distributed food.

The farm must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to do so may result in regulatory action, including seizure and/or injunction. A