FDA WARNING_LETTER - Shank Farms, Inc. - December 11, 2013

An FDA investigation of Shank Farms, Inc. on November 18 and December 11, 2013, confirmed the sale of an adulterated animal for slaughter. On July 4, 2013, a cow sold by Shank Farms was slaughtered, and USDA/FSIS analysis found desfuroylceftiofur, a marker residue for Ceftiofur, in the kidney at 1.23 ppm. This level exceeds the FDA tolerance of 0.4 ppm (21 C.F.R. § 556.113), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed inadequate conditions, indicating that medicated animals with harmful drug residues are likely to enter the food supply, violating section 402(a)(4) of the Act. Specifically, Shank Farms lacks an adequate system to ensure proper drug withdrawal times, fails to maintain treatment records, and lacks an adequate inventory system for drug quantities.

Shank Farms 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 of receiving the letter.