FDA WARNING_LETTER - Orth Farms LLC - October 29, 2013

On October 10-29, 2013, the FDA inspected Orth Farms LLC, a dairy operation in Eaton, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on May 22, 2013, Orth Farms sold a bob veal calf for slaughter. USDA/FSIS analysis of tissue samples from this animal on May 24, 2013, found 6.31 ppm of dihydrostreptomycin in kidney tissue. This exceeds the FDA tolerance of 2.0 ppm for cattle kidney tissue and is not permitted for bob veal calves, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also found that Orth Farms held 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).

Furthermore, Orth Farms engaged in extralabel use of the new animal drug (b)(4) (penicillin-dihydrostreptomycin in oil), NADA (b)(4), by administering it to dairy cows and allowing bob veal calves to access medicated colostrum without observing the 96-hour milk withholding period. This extralabel use was in or on feed, violating