FDA WARNING_LETTER - Hazenberg Dairy - April 03, 2008

An FDA inspection of Hazenberg Dairy (5828 Champoeg Road NE, Saint Paul, Oregon) on March 26, 28, and April 3, 2008, revealed multiple violations. The dairy sold five Holstein cows on July 17, 2007, and eight Holstein cows on October 18, 2007, for slaughter. Tissue samples from one cow sold in July showed penicillin residues of 0.71 ppm in kidney and 0.13 ppm in liver, exceeding the 0.05 ppm tolerance (21 CFR 556.510). A cow sold in October had sulfadimethoxine residues of 2.36 ppm in liver and 0.76 ppm in muscle, exceeding the 0.1 ppm tolerance (21 CFR 556.640). These levels caused the animals to be adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The inspection also found inadequate conditions, including a lack of an adequate system to ensure appropriate withdrawal times for medicated animals, incomplete treatment records, and failure to review records before slaughter, leading to adulteration under 21 U.S.C. § 342(a)(4). Furthermore, the extralabel use of penicillin G procaine was not in conformance with approved labeling