FDA WARNING_LETTER - John Balbian - September 18, 2013

On September 10 and 18, 2013, the FDA inspected Balbian Farm Road #5, a dairy operation in Amsterdam, NY. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act related to adulterated animals and new animal drugs.

Specifically, two bob veal calves sold for slaughter were found to be adulterated. A calf sold on April 30, 2013, had 14.93 ppm of neomycin residue in its kidney, and another sold on May 28, 2013, had 12.27 ppm. The FDA's tolerance for neomycin in cattle kidney is 7.2 ppm, but there is no acceptable level for neomycin in pre-ruminating calves when using certain medicated calf milk replacers. This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The operation also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4). Deficiencies included a failure to maintain treatment records and a lack of a system to verify incoming feeds, such as milk replacer containing neomycin sulfate and oxytetracycline hydrochloride, which have no tolerance level in pre-ruminating calves.

Furthermore, the new animal drugs neomycin sulfate and oxyt