FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
By Mark Durivage, Quality Systems Compliance LLC
On April 14, 2021, the FDA released a new guidance,
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency, to address the coronavirus disease 2019 (COVID-19) public health emergency. This guidance was implemented without prior public comment because the FDA determined that prior public participation was not feasible or appropriate. However, public comments may be submitted at any time for agency consideration.
During the COVID-19 public health emergency, the FDA is limiting unnecessary contact by only conducting prioritized domestic facility inspections and those that are deemed mission-critical. For unprioritized inspections, non-mission-critical domestic inspections, and inspections impacted by travel restrictions resulting from the public health emergency, the agency