FDA WARNING_LETTER - Imer Barton - May 16, 2014

On April 10, 18, and May 16, 2014, the FDA investigated Mr. Imer W. Barton's cattle dealer operation in Schoharie, New York. The investigation found violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, a dairy cow purchased and sold for slaughter on July 9, 2013, was found to have penicillin at 0.084 ppm in kidney tissue, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the operation held animals under insanitary conditions, leading to adulteration under section 402(a)(4) of the FD&C Act. Deficiencies included a lack of a system to ensure animals sold for slaughter were not medicated or, if medicated, withheld for appropriate withdrawal periods. The operation also failed to identify and record existing identification of purchased animals.

The FDA requires prompt corrective action to prevent recurrence, including: implementing a system to identify animals and trace them to their source; determining medication history and withdrawal periods from the source; withholding medicated animals from slaughter or clearly identifying them as medicated; and obtaining signed statements from sources confirming non-medicated status.