FDA WARNING_LETTER - Campbell Dairy Farm - December 04, 2013

On December 3 and 4, 2013, the FDA conducted an investigation of Campbell Dairy Farm in Limestone, Tennessee, resulting in a Warning Letter dated January 29, 2014. The inspection revealed significant violations concerning the adulteration and extra-label use of the new animal drug Prevail (flunixin meglumine). Specifically, the farm failed to use Prevail as directed by its approved labeling, constituting an extra-label use as defined by 21 CFR 530.3(a). Furthermore, this extra-label use was not conducted under the supervision of a licensed veterinarian, a direct violation of 21 CFR 530.11(a). These actions caused the drug to be unsafe under Section 512(a) and adulterated under Section 501(a)(5) of the Federal Food, Drug, and Cosmetic Act. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. The farm must notify the FDA in writing within 15 working days, detailing corrective steps, supporting documentation, and timelines for completion. Failure to comply may lead to further regulatory actions, including seizure or injunction.