FDA WARNING_LETTER - Bovina Dairy - May 17, 2017

On May 16-17, 2017, the FDA investigated Bovina Dairy, LLC, finding violations of the Federal Food, Drug, and Cosmetic Act. A culled dairy cow sold for slaughter on January 26, 2017, was found to have Sulfamethazine in its liver at 0.123 ppm, exceeding the 0.1 ppm tolerance, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also revealed insanitary conditions, specifically inadequate record-keeping for medicated animals, making it likely that animals with harmful drug residues could enter the food supply, which is adulteration under section 402(a)(4) of the Act. The dairy's animal treatment record system lacked complete information, including route of administration, dose, administrator, and withdrawal dates for initial and subsequent treatments.

Bovina Dairy's response to the FDA 483, Inspectional Observations, was deemed inadequate as it did not include an example process for maintaining accurate medication records or updated treatment protocols for Sulfamethazine, Penicillin G Procaine, Ceftiofur, and Florfenicol. The FDA requires prompt corrective action and a written response within fifteen working days detailing steps taken to correct violations and prevent recurrence, including documentation. Failure to comply may result in regulatory action such as seizure or injunction.