FDA Outlines Plan For Restarting Facility Inspections Halted Due To Pandemic

The FDA has published a roadmap for working through the backlog of facility inspections built up during the pandemic when it postponed all routine inspections in March 2020.

What Happened: The FDA warned that the emergence of new variants or other COVID-19 challenges could prevent it from conducting in-person inspections.

In the base-case scenario, FDA will work on mission-critical and priority domestic inspections for the next few months before resuming standard operations in July. If that happens, FDA expects to have cleared 26% of its backlog of medical products inspections by October.

The agency continued doing mission-critical inspections, carrying out eight device-related assessments and more than 800 in total from March 2020 to March 2021.

In July, FDA resumed prioritized domestic inspections and has since conducted 72 device assessments.

The activity has failed to prevent the build of a backlog of inspections. FDA has delayed seven device application decisions solely due to pending inspections or facility assessments.

As of March, FDA was yet to do 12 of the for-cause device inspections it plans to complete this fiscal year, which runs to the end of September.

In the base-case scenario, FDA will resume standard operations in July. The change will enable FDA to start chipping away at the backlog of 2,002 domestic surveillance inspections at its device unit, which also has a backlog of 424 foreign site visits.

The device department has a bigger backlog than the rest of the FDA’s human and animal medical products and tobacco groups combined. Including the device backlog, but not its food work, FDA has 3,229 domestic surveillance inspections remaining.

Why It Matters: Even if standard operations resume this month, FDA only expects to complete half of the domestic surveillance inspections in the current financial year under the report’s best-case scenario.

While there was a worst-case scenario outlined in the report, the agency did not offer any specific figure for how many inspections would be completed.

The FDA will continue to use remote assessment tools when possible but needs to be on-site for many outstanding inspections.

Notably, the annual Mammography Quality Standards Act mandates that inspections account for 25% of the remaining domestic assessments. FDA needs to visit sites in-person to perform those inspections.