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# FDA Scenarios for Future Inspections
- URL: https://www.fdaweb.com/fda-scenarios-for-future-inspections/
- Published: 2021-05-05T12:00:00.000Z
- Updated: 2026-09-14T16:57:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149258

FDA acting commissioner **Janet Woodcock** says the agency has developed scenarios with assumptions that can inform a return to more traditional inspection activities. In a [report](https://www.fda.gov/media/148197/download?utm%5Fmedium=email&utm%5Fsource=govdelivery), “Resiliency Roadmap for FDA Inspectional Oversight,” Woodcock says the agency “experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our inspection, surveillance, and compliance activities were significantly impacted. FDA fully understands the importance of getting back to a more consistent state of inspectional capacity. This plan provides the public with a transparent picture of both the successes and challenges we’ve faced in these areas over the last year, as well as our plan moving forward.”

The report describes the inspections that FDA was unable to complete during the past year due to travel restrictions or inability to ensure the safety of the agency workforce or the workforce at the entity being inspected.

From 3/2020 through 3/2021, FDA conducted 821 mission-critical inspections, including 29 in foreign countries, the report shows. It also conducted 777 prioritized domestic inspections since the resumption of that work in 7/2020\. The agency says that of 13,500 applications for medical product approval or authorization received since 3/2020, an estimated 68 applications have been delayed due to the inability to conduct inspections, with most of them not mission-critical.

Looking forward, Woodcock says, the agency is taking steps to resume standard operational levels of inspection activities and is looking at how it will prioritize domestic and foreign inspections that were not performed during the pandemic.

FDA has developed a series of scenarios given the continued uncertainty of the pandemic trajectory. Woodcock says that inspections considered critical to the agency’s mission will continue to be the primary focus. When planning routine surveillance inspections, the agency will prioritize higher-risk establishments.

The scenarios cover a gradual transition to standard operations with full transition by mid-summer, immediate transition to standard operations, and emergency operations status due to a resurgence of Covid-19 and tightened restrictions.

Woodcock says FDA will soon begin a multi-year modernization effort to further transform its data enterprise platforms and cross-program interoperability infrastructure to better support innovation related to the regulatory oversight role, including remote approaches. “This modernization effort will include a review of inspectional approaches using next-generation assessment technologies and improvements,” she says. “FDA is also establishing an agency-wide FDA Inspectional Affairs Council that will plan and coordinate inspectional activities.”