FDA WARNING_LETTER - R & J Haringa Dairy - June 07, 2013

The FDA conducted an investigation of R & J Haringa Dairy on May 15, 17, June 4, and 7, 2013, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm sold a dairy cow for slaughter that was adulterated, as tissue samples revealed penicillin residues at 0.075 ppm, exceeding the FDA tolerance of 0.05 ppm (21 CFR 556.510), violating section 402(a)(2)(C)(ii) of the FD&C Act. Additionally, the dairy held animals under insanitary conditions, specifically failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4).

The firm also adulterated new animal drugs, (b)(4) (Penicillin G Procaine) and (b)(4) (Ceftiofur Hydrochloride), through extralabel use not directed by their approved labeling. The extralabel use of (b)(4) involved incorrect dosage and unapproved indications, and was not under the supervision of a licensed veterinarian, violating 21 CFR 530.11(a). Similarly, (b)(4) was administered without following approved treatment duration, lacked veterinary supervision (21 CFR 530.11(a)), and is prohibited for extralabel use in cattle (21 CFR 530.41(a)(13)(ii)). These actions rendered the drugs unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act.

R & J Haringa Dairy must promptly correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions, timelines, and supporting documentation is required within fifteen working days to avoid potential regulatory actions such as seizure or injunction.