Minor QS Infractions Will Not Add Up To FDA Warning Letter
This article was originally published in The Silver Sheet
Executive Summary
"MINOR" QUALITY SYSTEM NONCONFORMITES uncovered during inspections will not trigger follow-up regulatory action under FDA's final revised medical device compliance program guide. Industry had argued that too many warning letters would result from the agency's draft plan to count numerous minor QS deviations as the basis for an "Official Action Indicated" inspection designation. The number of device QS warning letters issued by FDA in 1999 dropped by 18% compared to the 1998 total. Process validation and complaint-handling infractions continue to be prevalent as industry prepares for the agency's new quality systems inspection technique. WARNING LETTERS: Abbott Labs cited for QS reg deficiencies in the manufacture of Alcyon clinical chemistry analyzers; Sulzer BAK promotions contain "inappropriate" comparisons to Sofamor Danek device, FDA says