FDA Announces Modified Inspection Protocols

In order to ensure the safety and health of its workforce and regulated industry, on March 18, the U.S. Food and Drug Administration (FDA) announced that it was suspending routine domestic facility inspections in order to limit potential exposure to COVID-19 for investigators and workers at facilities. FDA had previously announced that it was suspending inspections at all non-U.S. locations.

FDA Commissioner Stephen Hahn specifically noted that only inspections that are normally carried out on a routinely scheduled basis (e.g., compliance with Current Good Manufacturing Practices) will be subject to suspension. All domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. FDA will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products. The agency is also considering conducting some of its routine inspection work remotely, through the review of documents if possible.

No timeline has been provided for when FDA might resume its normal inspection activities.