Sunland Dairy LLC – FDA Warning Letter, Jun 24, 2015

On August 5, 2015, the FDA issued a Warning Letter to Sunland Dairy, LLC, following an investigation on June 22 and 24, 2015, at their Tolleson, Arizona, dairy operation. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on February 9, 2015, Sunland Dairy sold a dairy cow for slaughter that was found to have penicillin residues of 0.354 ppm in kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510(a)). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the investigation found that animals were held under insanitary conditions, specifically a failure to maintain treatment records, which increases the likelihood of medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Sunland Dairy LLC is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions and timelines must be submitted to the FDA within fifteen working days of receiving the letter. Failure to comply may result in regulatory actions such as seizure or injunction.