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US FDA Takes A Scientific Look At Hot-Button Issue Of Unannounced Foreign Inspections

 
• By Bowman Cox

As Congress beats the drums for surprise inspections abroad, the agency plans a statistically rigorous comparison of announced versus unannounced inspections. Meanwhile, as authorities shed COVID-19 precautions, FDA investigators flood back into the field domestically, with surge of foreign inspections to follow soon.

Surprise!
not the best surprise • Source: Alamy

The US FDA is developing a scientifically rigorous answer to the growing demand from politicians for the agency to conduct unannounced surveillance inspections abroad like it did domestically before the pandemic.

The FDA is relying on a statistical model to conduct a controlled case study of announced versus unannounced inspections, and not just surveillance inspections, Alonza Cruse, director of the Office of Pharmaceutical Quality Operations in the FDA’s Office of Regulatory Affairs,

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