Exciting News!

As of April 1, 2023, Nexsen Pruet will merge with
Maynard Cooper & Gale. 

Together we are 

Maynard Nexsen Logo

We look forward to serving our clients from 23 offices and with 550 attorneys coast-to-coast.

The FDA Issues Report Regarding its Oversight Activities


The U.S. Food and Drug Administration (FDA) has faced many operational challenges during the COVID-19 pandemic. Early on, the FDA temporarily postponed routine surveillance facility inspections, conducting mission-critical inspections on a case-by-case basis. Since then, the FDA has leveraged its available tools and implemented innovative approaches to prioritize and resume some routine inspections and has been taking on-going, concrete steps to help stabilize its inspection and assessment operations and meet its oversight responsibilities.

On May 5, 2021, the FDA released a report entitled Resiliency Roadmap for FDA Inspectional Oversight that outlines the FDA’s approach to meeting its inspectional oversight responsibilities. The report details the state of the FDA’s inspectional oversight and its plan to address inspectional work postponed due to the COVID-19 pandemic. According to the report, the FDA will focus on conducting mission-critical inspections; continue to prioritize pre-approval, pre-market, pre-license, and for-cause inspections; and will ensure that high-priority risk-based inspections are completed before addressing postponed surveillance work.

The report also describes the FDA’s use of alternative tools and new approaches during the COVID-19 pandemic to provide some oversight of FDA-regulated products. The alternative tools and new approaches include the FDA’s (1) utilization of its authority under section 704(a)(4) of the federal Food, Drug, and Cosmetic Act, which permits the FDA to request from an establishment records or information pertaining to drug and biologic products, in advance of or in lieu of an inspection; (2) conducting of remote inspections on human and animal food importers under its Foreign Supplier Verification Program regulation; (3) utilization of information shared with the FDA by trusted state, local, tribal, territorial, and foreign regulatory partners; (4) use of risk-based product sampling and analysis; and (5) use of its authority to refuse entry of unsafe imported products. To better support such innovation and approaches related to its oversight responsibilities, the FDA intends to undertake a multi-year modernization effort to further transform its data enterprise platforms and cross-program interoperability infrastructure.

Recognizing the uncertainty caused by the COVID-19 pandemic, the FDA in its report details base-/best-/worst-case scenarios and their effects on progressing toward the resumption of standard operational levels. Each scenario estimates the surveillance work the FDA can reasonably accomplish given (1) a gradual transition to standard operations (Base-Case); (2) an immediate transition to standard operations (Best-Case); and (3) maintenance of an emergency-operations status (Worst-Case).

For further details regarding these scenarios or other information addressed in this article, please refer to the full report.

About Nexsen Pruet

Nexsen Pruet serves clients from nine offices across the Southeast. With more than 200 lawyers and professionals, the firm provides regional, full-service capabilities with international strengths.

Related Capabilities

Media Contact

Tina Emerson

Chief Marketing Officer

Direct: 803.540.2105

Photo of The FDA Issues Report Regarding its Oversight Activities
Jump to Page

Tracking Technologies and Advertising. You can set your browser to refuse all or some browser cookies or to alert you when cookies are being sent. If you disable or refuse cookies, we may not be able to provide you with the full features, functionality, or performance of our Sites.