FDA WARNING_LETTER - Dutch Cowboy Dairy LLC - May 07, 2012

On April 24 – May 7, 2012, the FDA inspected Dutch Cowboy Dairy, LLC, finding violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow delivered for slaughter on December 16, 2011, was found to have 4.12 ppm Dihydrostreptomycin in kidney tissue, exceeding the 2.0 ppm tolerance (21 CFR 556.200), rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also revealed insanitary conditions, specifically the failure to maintain an adequate system to ensure medicated animals are withheld from slaughter for appropriate periods to deplete drug residues, and the failure to maintain and review complete treatment records for medicated animals sold for food. These conditions cause food to be adulterated under section 402(a)(4) of the Act.

The FDA acknowledged the firm's May 5, 2012, letter disputing ownership of the cow but disagreed based on investigation findings. The firm's decision to stop using a Penicillin and Dihydrostreptomycin product was noted. The FDA found no evidence the firm was responsible for a separate Gentamicin residue.

Dutch Cowboy Dairy must take prompt action to correct violations and prevent recurrence. Failure to comply may result in regulatory action like seizure or injunction. A written response detailing corrective actions and timelines