FDA WARNING_LETTER - Chuctanuda Farms - December 20, 2011

The FDA issued a Warning Letter to Chuctanuda Farms following a December 2011 inspection at their Amsterdam, New York dairy operation, citing multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm sold a bob veal calf in July 2011, which, upon USDA/FSIS analysis, contained 8.0 ppm of dihydrostreptomycin in kidney tissue. As no acceptable residue level exists for this drug in bob veal calves, the food was deemed adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

Further deficiencies included holding animals under inadequate conditions, increasing the likelihood of medicated animals with harmful residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). The firm also failed to maintain complete treatment records.

Additionally, the new animal drug (b)(4) (penicillin-dihydrostreptomycin) was adulterated through extralabel use, not as directed by its approved labeling (21 C.F.R. 530.3(a)). This involved administering the drug in cow's colostrum to a bob veal calf, violating a 96-hour post-calving prohibition. This extralabel use was in or on feed (21 C.F.R. 530.11(b)) and caused illegal drug residue (21 C.F.R. 530.11(d)). The medicated colostrum itself was adulterated under 21 U.S.C. § 351(a)(6) by being fed to the calf, rendering the medicated feed unsafe.

Chuctanuda Farms must take prompt corrective action, establish preventative procedures, and respond to the FDA within fifteen working days, detailing steps taken and timelines. Non-compliance may lead to regulatory actions like seizure or injunction.