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Covance Laboratories, Madison, WI, Minneapolis District
A Covance laboratory facility in Madison, WI garnered a pair of 483s in GMP and GLP inspections that took place in the spring of 2000. The GMP inspection concluded March 10 and netted a two-item 483 while the GLP inspection, which concluded April 5, concluded with a one-item 483.
Prior to these visits, Covance's last full GMP inspection took place in June 1998 and was classified NAI while a prior GLP inspection was completed in December 1998 and was classified VAI, according to FDA records.
Covance fared somewhat better in the April 2000 GLP audit, which was conducted by FDA investigator Ronald Ruff. The firm received a 483, but this time the inspector cited only one deviation.
The 483 reads: "...This testing facility's management procedures did not properly assure that appropriate testing was conducted by another laboratory (the sponsor) in evaluating: 1) Stability of the test article and vehicle; and 2) Dose uniformity, …