FDA WARNING_LETTER - Twin Oaks Dairy, LLC - June 04, 2012

On May 24 and June 4, 2012, the FDA investigated Twin Oaks Dairy, LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated dairy cow for slaughter on January 2, 2012. USDA/FSIS analysis of tissue samples from this animal, slaughtered on January 3, 2012, revealed Dihydrostreptomycin in the kidney at 38.23 ppm, significantly exceeding the FDA tolerance of 2.0 ppm (21 C.F.R. § 556.200). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation found that the farm held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. Specifically, Twin Oaks Dairy failed to maintain an adequate inventory system for drugs used on cows and calves, constituting adulteration under section 402(a)(4) of the FD&C Act.

Twin Oaks Dairy must take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions, including documentation, is required within fifteen working days of receiving the letter. Failure to comply may result in regulatory actions such as seizure or injunction.