FDA ordered to ramp up unannounced foreign inspections

The omnibus spending bill recently signed by President Joe Biden directs the FDA to expand unannounced foreign facility inspections and evaluate them through a new pilot program.

The legislation includes $10 million for the program and a mandate to increase unannounced surveillance inspections of foreign drug establishments, Regulatory Focus reports.

The legislation also directs the FDA to evaluate “the differences between such inspections of domestic and foreign human drug establishments, including the impact of announcing inspections to persons who own or operate foreign human drug establishments in advance of an inspection.”

More specifically, the pilot program will evaluate significant differences between announced and unannounced inspections of foreign drug facilities, with a particular focus on differences in the number and type of violations of the Federal Food, Drug, and Cosmetic Act.

The pilot program will also evaluate, per t…

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