Do-n-Joy Holsteins – FDA Warning Letter, Dec 14, 2010

An FDA Warning Letter was issued to Do-N-Joy Holsteins following a December 14, 2010, investigation by the Minnesota Department of Agriculture at their dairy operation in Arlington, Minnesota. The investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act concerning the use of new animal drugs. Specifically, the firm was found to have adulterated penicillin G procaine, Sterile Penicillin G Procaine Injectable Suspension, by not using it as directed by its approved labeling. This constituted an extralabel use, which is only permissible under specific conditions outlined in 21 CFR Part 530, including supervision by a licensed veterinarian within a valid veterinarian/client/patient relationship. The firm's extralabel use of penicillin was not under such supervision, violating 21 CFR 530.11(a). Consequently, the drug was rendered unsafe under section 512(a) of the Act and adulterated under section 501(a)(5) of the Act. The FDA requires prompt corrective action to address these violations and implement procedures to prevent recurrence. The firm must respond in writing within 15 working days, detailing corrective steps and providing documentation, or explaining any delays. Failure to comply may lead to further regulatory actions, such as seizure or injunction, underscoring the firm's responsibility for overall operational and food distribution compliance.