FDA WARNING_LETTER - Zubrzycki Homestead - November 13, 2013

On November 5-13, 2013, the FDA inspected Zubrzycki Homestead, a dairy operation in Lowville, New York, and found violations of the Federal Food, Drug, and Cosmetic Act. The FDA determined that two bob veal calves sold for slaughter were adulterated.

Specifically, a calf sold on March 7, 2013, had 13.86 ppm of neomycin residue in its kidney, exceeding the 7.2 ppm tolerance and an acceptable level for veal calves. Another calf sold on July 11, 2013, had 11.07 ppm of neomycin residue in its kidney. The presence of neomycin in these amounts caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including failure to maintain complete treatment records and segregate treated animals, leading to adulterated food under section 402(a)(4). Furthermore, the firm engaged in extralabel use of neomycin sulfate and oxytetracycline in bob veal calves without a valid veterinarian/client/patient relationship, violating 21 CFR Part 530 and resulting in illegal residues (21 CFR 530.11(c)). This rendered the drugs unsafe and adulterated under sections 512(a) and 501(