FDA lays out plan to restart domestic inspections

July 13, 2020

It’s been about four months since the FDA stopped conducting most on-site inspections. But now the agency has created a roadmap for sending investigators back into facilities across the U.S.

Although the agency has continued to conduct “mission critical inspections” since the coronavirus outbreak began in March, the agency is now looking to expand its on-site surveillance activities.

In addition to targeting “prioritized domestic inspections,” the FDA will determine when and where it can safely send investigators by leveraging data from a COVID-19 Advisory Rating system, which tracks cases around the country. In order for the FDA to deem the site safe to travel to, the number of cases and hospitalizations in that county will have to be trending downward. The FDA will also consider other factors such as what reopening phase the county is in and what local necessities, such as public transportation, might be disrupted by the virus. 

Then, when going into facilities, the FDA will follow guidelines set by The White House and CDC to help ensure workplace safety when conducting inspections. The FDA also plans to pre-announce inspections so that the facility’s staff can take appropriate safety precautions.

The FDA said it is hoping to resume on-site surveillance starting the week of July 20. 

Read the full FDA statement.