FDA to resume on-site inspections in U.S.

The FDA intents to restart on-site inspections in the U.S., shut down in March due to the COVID-19 pandemic, the week of July 20.

Inspections will be prioritized according to a rating system based on real-time state and national data to assess the number of COVID-19 cases in a given area. The system will generate an “advisory level” based on the outcome of three metrics: phase of the particular state and county-level statistics on the current trend and intensity of infections.

County-level “advisories” will be parsed as: mission-critical inspections only, all inspections with caveats to help protect staff and resumption of all regulatory activities.

Inspections will be pre-announced to ensure the safety of all concerned with the exception of retail tobacco sites since they are undercover operations.

The agency says it will need to see a downward trend in new cases before upgrading an area to a less-stringent level.

https://seekingalpha.com/news/3590287-fda-to-resume-on-site-inspections-in-u-s