FDA WARNING_LETTER - Bob Osborn - July 26, 2011

On October 11, 2011, the FDA issued a Warning Letter to Robert L. Osborn following an investigation on July 12 and 26, 2011. The investigation concerned an animal sold for slaughter as human food on September 15, 2010.

The FDA found that an animal sold by Mr. Osborn for slaughter on September 15, 2010, and slaughtered on September 18, 2010, was adulterated. USDA/FSIS analysis of tissue samples from this cow (back tag (b)(4)) revealed gentamicin in the kidney tissue. The FDA has not established a tolerance for gentamicin residues in cattle edible tissues, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the investigation found that animals were held under insanitary conditions, making it likely that medicated animals with potentially harmful drug residues could enter the food supply. Specifically, Mr. Osborn failed to maintain treatment records. This constitutes adulteration under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

Mr. Osborn was instructed to take prompt action to correct the violations and