FDA 483 - Scenic View Dairy, LLC - January 07, 2008

An FDA inspection of Scenic View Dairy LLC, a dairy farm located at 1510 62nd St, Fennville, MI, was conducted from December 18, 2007, to January 7, 2008. The inspection identified five observations.

Observation 1 noted the use of Penicillin contrary to label directions, specifically administering 100cc, 40cc, and 60cc doses to dairy cows, while the label specifies 1cc per 100lbs body weight (3,000 units per pound). This was done without a valid veterinary client-patient relationship.

Observation 2 detailed violative drug residues in dairy cows offered for human consumption. A cow slaughtered on June 19, 2007, had Sulfadimethoxine levels of 0.24 ppm in the liver and 0.20 ppm in the muscle, exceeding the 0.1 ppm tolerance. Another cow slaughtered on October 17, 2007, had a Penicillin level of 0.24 ppm in the kidney, exceeding the 0.05 ppm tolerance.

Observation 3 cited incomplete treatment records. Written and computer-generated medical records lacked consistent documentation of route of administration, dosage, and withdrawal times for drugs used, including for a cow that later had a violative Penicillin residue.

Observation 4 indicated a failure to