FDA WARNING_LETTER - Cody L Emberton - May 18, 2011

On May 12-18, 2011, the FDA investigated Cody L. Emberton's farm operation at 1648 Whites Chapel Road, Glasgow, KY. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on November 10, 2010, Emberton sold a cow for slaughter that was found to be adulterated. USDA/FSIS analysis of liver tissue from this animal, slaughtered on November 17, 2010, detected 2.845 ppm of Tilmicosin, exceeding the FDA tolerance of 1.2 ppm (21 C.F.R. § 556.735). This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act.

Furthermore, the investigation found insanitary conditions, including a failure to maintain treatment records for medicated animals and the presence of expired prescription drugs in storage. These conditions mean food from animals held under them is adulterated under section 402(a)(4) of the Act.

Emberton 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. A written response detailing corrective actions and timelines is required within fifteen working days to Stephen J. Rabe, Compliance Officer.