On July 10, 2020, the U.S. Food and Drug Administration (FDA) stated their plan on restarting onsite domestic inspections. In March, FDA had reduced inspections due to the COVID-19 pandemic, and they have only been conducting mission critical inspections over this period. FDA Commissioner Stephen Hahn said in a statement that FDA is “working toward the goal of restarting on-site inspections during the week of July 20.” A new COVID-19 Advisory Rating System is being employed in order for the FDA to judge the risks before entering a site. Investigators will have the necessary protective wear and gear, and manufacturers should be fully prepared for inspections. It is expected for there to be a heightened line of communication between industry and the Agency.
The future for OUS firms and products, however, is even less clear than domestic ones as the FDA has not yet identified when international inspections will restart.
It’s unclear whether resuming inspections will cause issues for the FDA and the medical industry. Most quality experts agree that companies have continued following their quality management system during the pandemic, but this may not be true as many workers have been completing tasks remotely. The FDA always relies on the voluntary compliance of industry, so there is concern that some companies have fallen complacent during this period of FDA leniency and scheduled events like internal audits, management reviews, complaint trending or adverse notification timelines have been delayed. Corrective actions and non-conforming reporting may have also been neglected due to remote Quality staffing. There may be an increase of 483 observations and warning letters as companies scramble to bring systems back online; there may also be a large number of recalls since some products have been released through the EUA process without full regulatory review or quality management.
If you’d like to learn more about FDA’s foreign and domestic inspection programs and/or how COVID-19 may affect your company, please contact the FDA compliance experts here at MEDIcept.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.