FDA has a goal of restarting on-site inspections during the week of July 20 — four months after it temporarily halted them — though there will be changes due to the COVID-19 pandemic.
The agency today said that it will pre-announce inspections to FDA-regulated businesses. Said FDA: “This will help assure the safety of the investigator and the firm’s employees, providing the safest possible environment to accomplish our regulatory activities, while also ensuring the appropriate staff are on-site to assist FDA staff with inspection activities.”
FDA is also outfitting its inspectors with personal protective equipment and other necessary items so that they adhere to state and local guidelines.
One top of that, FDA has also created a ratings system to determine where it is safest to conduct prioritized domestic inspections, based on the number of COVID-19 cases in a local area. FDA is making COVID-19 Advisory Rating system data available not only to its own investigators but also to state partners who carry out inspections of FDA-regulated entities on the agency’s behalf under contract.
A particular county’s COVID-19 Advisory Level will determine whether FDA conducts only mission-critical inspections, or brings back all inspections with caveats for staff especially vulnerable to the virus, or resumes all regulatory activity.