FDA Implements Formal Timeframe for Post-Inspection Responses

Global Life Sciences: US-FDA Update

The Food and Drug Administration (FDA) has recently revised its internal processes to increase the speed and visibility of its enforcement actions. These changes include (1) the implementation of a formal timeframe for the submission and agency review of post-inspection responses to FDA 483 observations and (2) process revisions to reduce delays in disqualification and debarment proceedings. Both of these changes have important consequences for firms subject to FDA inspections.