Bloomberg Law
March 17, 2022, 9:25 AMUpdated: March 17, 2022, 5:21 PM

Quality Concerns to Resurface as FDA Resumes Foreign Inspections (1)

Celine Castronuovo
Celine Castronuovo

The robustness of the FDA’s foreign inspections program will get a renewed focus as the agency resumes global surveillance activities following a pandemic pause.

The Food and Drug Administration brought back domestic surveillance inspections in February and plans to begin conducting foreign prioritized inspections in April.

As the FDA addresses a nearly two-year inspection backlog, attorneys say the agency should also use this moment to address repeated complaints with its foreign inspection practices. They argue that boosting agency staff, utilizing unannounced inspections, and hiring more independent translators can lead to more accurate FDA reviews.

“One of the biggest problems here ...

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