FDA WARNING_LETTER - Clayholm Farms, LLC. - April 16, 2015

On April 16, 2015, the FDA investigated Clayholm Farms, LLC, a dairy operation in Worthington, Pennsylvania, and found violations of the FD&C Act. The investigation revealed that on May 9, 2014, Clayholm Farms sold a dairy cow for slaughter with desfuroylceftiofur (ceftiofur marker residue) in its kidney tissue at (b)(4) ppm, exceeding the FDA tolerance of 0.4 ppm. This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the FDA found that Clayholm Farms held animals under insanitary conditions, specifically failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

The firm also adulterated the new animal drug (b)(4) (ceftiofur crystalline free acid, (b)(4)) by using it extralabelly without following the withdrawal period and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and resulting in an illegal drug residue, violating 21 C.F.R. 530.11(d). This caused the drug to be unsafe and adulterated