McGovern Farm, Inc. – FDA Warning Letter, Jun 8, 2012

On June 28, 2012, the FDA issued a Warning Letter to McGovern Farm, Inc. following an investigation from April 23 to June 08, 2012. The investigation confirmed that a cow sold by McGovern Farm on July 26, 2011, for slaughter for human food, was adulterated under Section 402(a)(2)(C)(ii) of the FD&C Act.

Specifically, tissue samples from the slaughtered animal revealed 0.47 ppm of Desfuoylceftiofur in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. 556.113(b)). Additionally, Sulfadimethoxine was found at 0.153 ppm in liver tissue and 0.15 ppm in muscle, exceeding the FDA tolerance of 0.1 ppm (21 C.F.R. 556.640(b)).

The FDA requires prompt corrective action to prevent recurrence, warning that failure to comply may result in regulatory actions like seizure or injunction. To avoid future violations, McGovern Farm should implement systems for animal traceability, determine prior medication use, and ensure appropriate withdrawal periods or clearly identify medicated animals not intended for human food. A written response detailing corrective actions and timelines is required within fifteen working days.