Holmes Acre LLC – FDA Warning Letter, Mar 25, 2015

On March 16 and 25, 2015, the FDA inspected Holmes Acre LLC's dairy operation and found multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm offered two bob veal calves for slaughter with illegal neomycin residues (8.38 ppm and 10.77 ppm in kidney), exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for bob veal calves, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). The operation also held animals under insanitary conditions, making it likely that medicated animals with harmful residues would enter the food supply, violating 21 U.S.C. 342(a)(4). Furthermore, the firm adulterated new animal drugs (neomycin sulfate, oxytetracycline hydrochloride, lasalocid) through extra-label use, including administering them to unapproved animal classes and for longer durations than specified. These extra-label uses were not under licensed veterinarian supervision (21 CFR 530.11(a)) and resulted in illegal drug residues (21 CFR 530.11(c)), causing the drugs to be unsafe and adulterated under 21 U.S.C. 360b(a) and 351(a)(5). Medicated milk replacers were also adulterated (21 U.S.C. 351(a)(6)) and rendered unsafe (21 U.S.C. 360b) due to non-conformance with approved labeling regarding animal class. The FDA requires prompt corrective action within 15 working days, with documentation, to prevent recurrence, warning that failure to comply may lead to regulatory actions like seizure or injunction.