FDA WARNING_LETTER - Nickerson Brothers - June 18, 2015

On June 3, 10, 12, and 18, 2015, the FDA inspected Nickerson Brothers' dairy operation in Arcade, New York, and found violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation involved the sale of an adulterated dairy cow for slaughter on February 19, 2015. USDA/FSIS analysis of tissue samples from this animal, slaughtered on February 20, 2015, revealed 2.22 ppm of desfuroylceftiofur (ceftiofur marker residue) in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. 556.113). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation found insanitary conditions, specifically a failure to maintain treatment records and identify treated animals, leading to the likelihood of medicated animals with harmful drug residues entering the food supply. This renders food adulterated under section 402(a)(4) of the FD&C Act.

The firm also adulterated the new animal drug Excede (Ceftiofur Crystalline Free Acid) by using it extralabelly without following the approved label's withdrawal time and without the supervision of a licensed veterinarian, violating