FDA WARNING_LETTER - Parker's Dairy Inc. - September 25, 2015

On August 3 and September 25, 2015, the FDA inspected Parker's Dairy Inc. and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated bob veal calf for slaughter on December 11, 2014. USDA/FSIS analysis revealed 27.89 ppm of neomycin residue in the calf's kidney, exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for veal calves. This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the FDA found insanitary conditions, specifically the failure to identify a medicated animal sold at auction and incomplete treatment records, leading to potential harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

The company also adulterated the new animal drug Neomycin Oral Solution by using it extralabelly on a bob veal calf without following approved labeling for animal class and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and (c). This extralabel use resulted in an illegal drug residue, making the drug unsafe and adulterated under sections 512(a) and 501(a)(5) of