Annotated 483s deemed "worthwhile" by 81% of inspectors -- FDA survey.
This article was originally published in The Gray Sheet
Executive Summary
PRE-ANNOUNCED INSPECTIONS COMPRISE 80% OF ALL DEVICE INSPECTIONS under FDA's pilot program giving nonviolative device companies advance notice of an inspection. Of 640 device firms inspected since the agency commenced the pilot April 3, 513 have been preannounced.