FDA WARNING_LETTER - Jason Martindale - June 06, 2013

On May 30 and June 5-6, 2013, the FDA inspected Riverview Ranch and Livestock's calf grower operation in Gansevoort, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on April 9, 2013, Riverview Ranch sold a bob veal calf for slaughter that was found to have unsafe levels of tulathromycin in its kidney tissue, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). FDA has not established a tolerance for tulathromycin in preruminating calf kidney tissue.

Additionally, the operation was found to hold animals under insanitary conditions, failing to maintain treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).

The new animal drug (b)(4) (tulathromycin) Injectable Solution Antibiotic (NADA (b)(4)) was also found to be adulterated under 21 U.S.C. 351(a)(5). Riverview Ranch used this drug extralabelly, administering it to a bob veal calf without following approved labeling or veterinarian's directions, and without the supervision of a licensed veterinarian, violating 21 C.F.R