FDA WARNING_LETTER - King Ransom Farm LLC - April 20, 2012

On April 11-13, 17, and 20, 2012, the FDA inspected King Ransom Farm LLC's dairy and bull breeding operation in Northumberland, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on December 29, 2011, King Ransom Farm LLC sold a bob veal calf for slaughter. USDA/FSIS analysis of tissue samples from this animal on December 30, 2011, found 15.83 ppm of neomycin in the kidney tissue. This exceeds the FDA tolerance of 7.2 ppm for neomycin in cattle kidney tissue (21 C.F.R. 556.430) and is not permitted for bob veal calves, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that the farm held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act. This was evidenced by a failure to maintain complete treatment records.

Furthermore, the new animal drug (neomycin sulfate and oxytetracycline hydrochloride) was adulterated because it was used extralabelly, specifically administered to a bob veal calf without following approved