FDA WARNING_LETTER - Brouillette Farm, Inc. - May 17, 2012

On April 17, 23, and May 17, 2012, the FDA investigated Brouillette Farm, Inc. in Richford, VT, and found violations of the Federal Food, Drug, and Cosmetic Act. Specifically, on January 23, 2012, the farm sold a cow for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on January 24, 2012, revealed flunixin residues of 3.34 ppm in liver tissue and 0.0369 ppm in muscle. These levels exceed the FDA tolerances of 0.125 ppm for liver and 0.025 ppm for muscle, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that the farm holds animals under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. Deficiencies included failure to maintain drug treatment and inventory records, and lack of an adequate system to discard expired drugs. These conditions cause food to be adulterated under section 402(a)(4) of the FD&C Act. Brouillette Farm, Inc. must take prompt action to correct these violations and establish procedures to prevent recurrence within fifteen working days, or face potential regulatory actions like seizure or