FDA WARNING_LETTER - Butterfield Dairy, LLC - April 29, 2015

On April 29, 2015, the FDA inspected Butterfield Dairy, LLC, in Buckeye, Arizona, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy offered for sale an adulterated animal for slaughter. Specifically, on January 29, 2015, a cow sold for slaughter was found to have 0.05 ppm of ampicillin in its kidney tissue, exceeding the FDA tolerance of 0.01 ppm (21 C.F.R. § 556.40). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the FDA found that the dairy held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. A specific deficiency noted was the failure to maintain complete treatment records. This violates section 402(a)(4) of the FD&C Act, deeming the food adulterated due to insanitary conditions.

Butterfield Dairy, LLC, is responsible for ensuring compliance and must take prompt action to correct these violations and prevent recurrence. Failure to do so may result in regulatory actions like seizure or injunction. The dairy must respond in writing within fifteen working days, detailing corrective steps taken or planned, including documentation. If corrections cannot be completed within this timeframe, the reason for delay and a new timeline must be provided