FDA 483 - Scenic View Dairy, LLC - February 02, 2010

On February 2, 2010, the FDA issued a Form 483 to Scenic View Dairy, LLC, located at 1510 62nd St, Fennville, MI 49408-8541. The inspection, conducted from January 25 to February 2, 2010, identified two observations.

Observation 1 noted that a cow sold for human food on August 11, 2009, had Sulfadimethoxine (SDM) residues exceeding the tolerance level of 0.1 ppm. Specifically, the cow's liver contained 0.151 ppm and muscle contained 0.125 ppm of SDM, indicating use of the drug contrary to its labeling, resulting in residues above the established safe level.

Observation 2 cited the failure to implement a system for controlling drug administration to animals. The firm treated a cow with SDM for foot rot on August 2, 3, 4, and 5, 2009. However, the animal treatment record for this cow did not specify the actual dosage amount for each SDM treatment on these dates.

The recipient of the report was Mr. Mark A. Lucas, Partner/Manager. The FEI number for the firm is 3003380618. The inspection was performed by Investigator Tonnie L. Carter.