FDA Prepares for Resumption of Domestic Inspections

14 July 2020

GMP News

The FDA will resume “prioritized” domestic manufacturing inspections the week of July 20 after a four-month moratorium on most on-site walkthroughs, FDA Commissioner Stephen Hahn said in a release Jul 10.

However, a troubling uptick in new COVID-19 cases and deaths means the agency will weigh local virus activity when deciding which sites to inspect, and that fact had analysts questioning the FDA’s announcement.

In a sign of “chaotic federal messaging,” Cowen analysts said in a Friday note, the FDA will draft its own risk criteria, based on local and state infection data, to pick and choose those facilities. And Hahn warned the agency would need to see a major shift in new COVID-19 cases before resuming operations fully.

“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,” Hahn said. “In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area.”

Meanwhile, as a safety measure for employees, Hahn said investigators would pre-announce their visits rather than making unplanned inspections. The only exception to that rule will be on retail tobacco sites “as they are undercover operations where the retailer is unaware an inspection is taking place,” Hahn said.

The FDA’s partial greenlight on inspections comes months after the administration telegraphed that it was working on a “phased approach to jumpstart site walkthroughs. Previously, investigators were only running inspections on facilities determined as ‘mission-critical,'” Hahn said.

The agency’s interim plan might give foreign drug manufacturers hope that things will get back to normal.




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