FDA on Inspections During and After Pandemic

Pharmaceutical Technology Editors

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

FDA released a report on May 5, 2021 providing an overview of the agency’s inspectional activities during the COVID-19 pandemic and plans for inspection operations in the future. FDA postponed domestic and foreign inspections in March 2020 in response to the pandemic and began domestic inspections again in July 2020 using a rating system to prioritize those facilities where inspections were most needed.

According to FDA, the agency conducted 821 mission-critical inspections from March 2020 through March 2021; 29 of those inspections were in foreign countries. A total of 777 prioritized domestic inspections were conducted since the agency resumed domestic inspections in July 2020. The report also outlines when the agency used alternative tools, such as remote livestreaming video, teleconferences, or screen sharing, when in-person inspections were not feasible.

FDA is planning a variety of scenarios for conducting inspections during the ongoing pandemic, with critical inspections being a primary focus and other higher-risk facilities being prioritized. Longer intervals between inspections will continue for less high-risk facilities, according to the agency, and postponed inspections will be prioritized based on risk and conducted over a longer period of time.

The agency is planning a multi-year modernization to transform its data enterprise platforms and cross-program interoperability infrastructure, which will include a review of next-generation assessment technologies. In addition, an agency-wide FDA Inspectional Affairs Council will be created to plan and coordinate inspectional activities.

“Like most organizations around the world, the FDA experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our inspection, surveillance, and compliance activities were significantly impacted,” said Acting FDA Commissioner Janet Woodcock, MD, in a press release. “The 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 past year, as well as our plan moving forward. We want to assure the American public that we have used a variety of tools to oversee the regulated industry and ensure that Americans continue to have access to safe food and high-quality FDA-regulated products.”

Source: FDA