FDA WARNING_LETTER - Falling Star Farm, Ltd. - May 21, 2013

On April 23 and May 21, 2013, the FDA inspected Falling Star Farm, Ltd., a dairy operation in Polk, Ohio. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on November 12, 2012, the farm sold a bob veal calf for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from the calf, slaughtered on November 13, 2012, detected 24.3 ppm of neomycin in the kidney. This exceeds the FDA tolerance of 7.2 ppm for neomycin in uncooked edible kidney tissue of cattle (21 C.F.R. 556.430(b)(1)). Furthermore, there is no acceptable residue level for neomycin from Advance Calvita Supreme Medicated All Milk - Calf Milk Replacer in veal calves, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Additionally, the drugs neomycin and oxytetracycline, contained in Advance Calvita Supreme Med