An FDAnews analysis of the FDA’s GMP inspection reports for the year shows that drugmakers continue to stumble at the same old hurdles.
Failure to document quality unit responsibilities and procedures was once again the top citation in the agency’s Form 483 reports. It’s been the top citation for over a decade — often by a wide margin.
This year, the agency logged 185 instances of the violation, 50 more times than the second most frequent GMP lapse, which was failure to thoroughly review unexplained discrepancies or batch/component failures to meet specifications. The agency observed that failure 135 times compared to 107 in 2018, moving it up from third to second place.