FDA Eyes Imminent Resumption of Physical Inspections

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The U.S. Food and Drug Administration (FDA) is “working toward the goal of restarting onsite inspections during the week of July 20,” Commissioner Stephen M. Hahn, MD, said on July 10. “However, resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality, and the rules and guidelines that are put in place by state and local governments,” he added.

In order to move to the next phase, FDA must see downward trends in new cases of COVID-19 and hospitalizations in a given area. “Our ability to resume is also affected by other services that have been curtailed by the pandemic, such as public transportation,” Hahn said. “The availability of these services will be an important factor in how we determine resuming domestic inspections.”

The FDA has also determined that, for the foreseeable future, prioritized domestic inspections will be pre-announced to many FDA-regulated businesses. “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 onsite to assist FDA staff with inspection activities,” Hahn said.

FDA inspectors haven’t been idle, Hahn stressed. “Despite pausing onsite surveillance inspections in the U.S. in March, our investigators have conducted mission-critical inspections and other activities to ensure FDA-regulated industries are meeting applicable FDA requirements,” he said. “We have had great success by using a number of tools as part of the agency’s risk-based approach to ensuring quality, including remote assessments and import alerts, as well as other compliance requirements.”

Edited by Michael Causey