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WARNING LETTER
•Hyman Farms•March 29, 2013

Hyman Farms – FDA Warning Letter, Mar 29, 2013

Record Details

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.

Company
Hyman Farms
Inspection date
March 29, 2013
Product type
Drugs
Office
Dallas District Office
People
  • William B. Settle
  • Reynaldo Rodriguez (District Director)
View Company Profile

ID · 4ea9acbe-70f2-4ecd-a305-fe7b00c14497

Violation Codes6
FD&C Act 402(a)(2)(C)(ii)21 U.S.C. 342(a)(2)(C)(ii)FD&C Act 51221 U.S.C. 360bFD&C Act 402(a)(4)21 U.S.C. 342(a)(4)

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