FDA WARNING_LETTER - Mountain Vista Dairy - October 18, 2012

On October 15-18, 2012, the FDA inspected Mountain Vista Dairy in Tillamook, Oregon, and found violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on May 9, 2012, was found to have 0.25 ppm of penicillin in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions likely to lead to contaminated food, including incomplete treatment records, a lack of a drug inventory system, and expired veterinary drugs available for use, violating 21 U.S.C. § 342(a)(4).

Furthermore, the firm engaged in extralabel use of Pro-Pen-G® Injection (Penicillin G Procaine Injectable Suspension) by not following the approved dosage and amount per injection site, and this extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This rendered the drug unsafe and adulterated under 21 U.S.C. § 360b(a) and 21 U.S.C. § 351(a)(5).

The FDA acknowledged the firm's