FDA Announces Plan to Relaunch Onsite Facility Inspections

The FDA has announced a partnership with the Centers for Disease Control and Prevention (CDC) to develop a plan for relaunching surveillance inspections. The agency is aiming for a phased approach to restarting on-site inspections of domestic and foreign drug manufacturing facilities following criteria outlined in the White House Guidelines for Opening Up America Again.

Onsite facility inspections performed by the FDA were shut down in March due to the coronavirus pandemic. Some inspections that were determined to be “mission critical” have been carried out by the agency on a case-by-case basis with appropriate safety measures. Alternative quality control methods, like physical product inspections at the border, review of previous compliance records, and communication with foreign governments on inspection information, have been implemented during the shutdown.

The agency hopes restarting inspections will help drug manufacturers get their supply chains back in order after nationwide shortages of critical drugs caused by the pandemic.

In late May, the FDA released new guidance regarding products seeking approval through the Humanitarian Device Exemption and Premarket Approval routes, which require on-site inspections. The new rule would allow manufacturers applying for these approvals to make manufacturing site changes without an on-site inspection as long as the change does not create “undue risk” and the site had “established good manufacturing practices” previously.

Sources: FDA investor note, May 11, 2020; Fierce Pharma, May 14, 2020;

FDA guidance document, May 21, 2020.