FDA WARNING_LETTER - Wingert Farms, Inc - February 02, 2015

On January 20, 21, 22, and February 2, 2015, the FDA inspected Wingert Farms, Inc. in Alexandria, Pennsylvania. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the new animal drug Prevail (flunixin meglumine) Injectable Solution, ANADA 200-308, was found to be adulterated.

The key violation was the extralabel use of Prevail (flunixin meglumine) Injectable Solution. The drug was administered to a dairy cow (ear tag (b)(4)) without adhering to the withdrawal period specified in the approved labeling and the servicing veterinarian's written prescription. This constituted an extralabel use as defined under 21 C.F.R. 530.3(a). Furthermore, this extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a).

Because the drug's use did not conform to its approved labeling and failed to comply with 21 C.F.R. Part 530, it was deemed unsafe under section 512(a) of the FD&C Act (21 U.S.C. § 360b(a)) and adulterated under section 501(a)(5)