FDA 483 - Scenic View Dairy, LLC - September 18, 2009

An FDA inspection of Scenic View Dairy LLC, a dairy farm located at 1510 62nd St, Fennville, MI, was conducted from August 14, 2009, to September 18, 2009. The inspection identified four observations.

Observation 1 noted a violative drug residue: on January 5, 2009, a dairy cow (Ear Tag (b)(4)) sold for human consumption had a Flunixin level of 0.1525 ppm in the liver, exceeding the 0.125 ppm tolerance.

Observation 2 cited the use of an animal drug contrary to label directions without a valid veterinary-client-patient relationship. Penicillin was routinely administered at 40 cc per 24-hour period, despite the label indicating 1 cc per 100 pounds body weight, without a veterinary prescription authorizing the excess dosage. Examples included cows with Ear Tags (b)(4), (b)(4), and (b)(4) receiving 40 cc of Penicillin.

Observation 3 indicated a failure to follow the veterinarian's prescribed route of administration. On December 30, 2008, a dairy cow (Ear Tag (b)(4)) was given Flunixin via Intramuscular (IM) route, while the prescription specified slow Intravenous (IV) administration.

Observation 4 detailed