FDA WARNING_LETTER - Hillcrest Homestead LLC - September 21, 2015

On September 9-21, 2015, the FDA inspected Hillcrest Homestead LLC's dairy operation. The investigation found the company offered an adulterated animal for slaughter, violating the Federal Food, Drug, and Cosmetic Act.

Specifically, a calf sold on June 29, 2015, and slaughtered on June 30, 2015, contained 30.53 ppm of neomycin in kidney tissue, exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for veal calves, rendering the food adulterated per 21 U.S.C. § 342(a)(2)(C)(ii).

The FDA also found insanitary conditions, including incomplete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, violating 21 U.S.C. § 342(a)(4).

Furthermore, Hillcrest Homestead LLC adulterated the new animal drug Vet One Neomycin by using it extra-label without veterinary supervision, not following approved animal class, administering it in feed, and causing an illegal residue, violating 21 CFR Part 530 and rendering the drug unsafe (21 U.S.C. § 360b(a)) and adulterated (21 U.S.C. § 351(a)(5)). The animal feed was also