FDA 483 - Brook View Dairy, L.L.C. - October 01, 2009

During an FDA inspection from August 11, 2009, to October 1, 2009, Scenic View Dairy, LLC, a dairy farm located at 10560 Freeport Ave, Freeport, MI, was issued a Form FDA 483 with three observations. Michael J. Van Dam, Farm Manager, was the recipient of the report.

Observation 1 noted that the firm caused a violative drug residue in an animal sold for human consumption. Specifically, on November 25, 2008, a dairy cow (Ear Tag #) sold for slaughter had a kidney tissue Penicillin level of 0.10 ppm, exceeding the 0.05 ppm tolerance.

Observation 2 cited the use of an animal drug contrary to label directions without a valid veterinary client-patient relationship. The firm routinely administered 20 cc and/or 40 cc of Penicillin (Pen G, Pen) within a 24-hour period, while the label dosage is 1 cc per 100 pounds body weight. No veterinary prescription authorized this excess dosage. An example provided was a cow (Ear Tag #) administered 40 cc on November 10, 2008, and 20 cc on November 11, 12, and 13, 2008.

Observation 3 indicated incomplete treatment records. The firm did