FDA WARNING_LETTER - Hyman Farms - March 29, 2013

On March 28-29, 2013, the FDA investigated Hyman Farm Service LLC's dairy operation in Dimmitt, TX, finding violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on May 10, 2012, was found to have gentamicin in its kidney tissue by USDA/FSIS analysis. FDA has no established tolerance for gentamicin in cattle, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

The FDA acknowledged an April 4, 2013, response from Mr. William B. Settle, Manager, but deemed it insufficient due to a lack of detail and examples of implemented medication treatment records. Hyman Farm Service LLC is required to provide a written response within fifteen working days, detailing corrective actions, prevention measures, and supporting documentation. Failure to comply may result in regulatory actions like seizure or injunction.