FDA WARNING_LETTER - Donald Potts - June 25, 2013

On July 24, 2013, the FDA issued a Warning Letter to Mr. Donald Potts, co-owner of a dairy farm in Montrose, Pennsylvania, following a June 25, 2013, investigation. The letter stated that a bob veal calf sold for slaughter on February 14, 2013, was adulterated. USDA/FSIS analysis of tissue samples from the calf, slaughtered on February 15, 2013, revealed Neomycin at 132.48 ppm in kidney tissue, exceeding the 7.2 ppm tolerance for cattle, and Flunixin in kidney tissue, which is not permitted for veal calves. This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, specifically due to a failure to maintain complete treatment records. This violates section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug Neomycin Oral Solution (ANADA #200-379) was adulterated because it was used extralabelly on a bob veal calf, a class of animal not specified on the approved labeling. This extralabel use was not under the supervision of a licensed veterinarian and resulted in an illegal