FDA WARNING_LETTER - Flood Brothers, LLC - November 19, 2014

On November 4, 6, and 19, 2014, the FDA investigated Flood Brothers, LLC, a dairy operation in Clinton, ME. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on or about August 25, 2014, Flood Brothers sold a dairy cow for slaughter that was found to have flunixin at 0.253 ppm in its liver tissue, exceeding the established tolerance of 0.125 ppm. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), as it contained an unsafe new animal drug.

Furthermore, the investigation found that animals were held under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. This includes a failure to maintain complete treatment records. Such conditions cause food to be adulterated under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).

Flood Brothers is responsible for ensuring compliance and must take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to do so may result in regulatory action, including seizure and/or injunction. A written response detailing corrective