FDA resumes on-site domestic inspections

The FDA is resuming on-site inspections of facilities that manufacture FDA-regulated products after pausing all domestic inspections in March due to COVID-19 concerns. 

The agency said July 10 that it is using White House and CDC guidelines or safely resuming inspections and protecting workplaces against COVID-19. 

The FDA temporarily halted all domestic inspections in March and directed most of its employees to telework. It continued "mission critical" inspections during that time.

The FDA said it plans to resume on-site inspections next week but needs to see declines in new cases of COVID-19 and hospitalizations in an area before it will conduct an inspection there. 

The agency said it has developed a COVID-19 advisory rating system to help determine when and where it's safest to conduct inspections and will prioritize inspections based on risk.

The system uses real-time data to assess the number of COVID-19 cases in an area based on state and national data and will tell the FDA where it is best to conduct on-site inspections. 

The agency said its ability to resume inspections is also affected by other services affected by COVID-19, such as public transportation.

Inspections will be announced to ensure the safety of FDA  investigators and the employees of the firm being inspected, the FDA said. Typically, inspections are not announced. It still won't announce inspections of tobacco firms. 

Investigators will wear personal protective equipment and adhere to state, local and CDC guidance for proper COVID-19 protective measures, the agency said. 

Read the full news release here.

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