FDA WARNING_LETTER - Short Branch Farms LLC - May 18, 2011

On May 12-18, 2011, the FDA investigated Frankie C. Froggett dba Short Branch Farms, LLC, and found violations of the Federal Food, Drug, and Cosmetic Act. A cow owned by the farm, offered for slaughter on November 10, 2010, and slaughtered on November 17, 2010, by (b)(4) Wyalusing, PA, was found to be adulterated. USDA/FSIS analysis of liver tissue from this animal identified 2.845 ppm Tilmicosin, exceeding the FDA tolerance of 1.2 ppm (21 C.F.R. § 556.735). This violates section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), deeming the food adulterated due to unsafe new animal drug residues.

Additionally, the investigation revealed insanitary conditions, specifically the failure to control drug administration and maintain treatment records for animals. This allows medicated animals with potentially harmful drug residues to enter the food supply, adulterating food under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).

The FDA requires prompt corrective action and establishment of procedures to prevent