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US FDA foreign inspections "need better follow-up"

This article was originally published in Scrip

Executive Summary

The US FDAshould conduct more timely follow-up visits to foreign drug establishments that have received warning letters citing manufacturing deficiencies, the Government Accountability Officesaid. Congress's investigative arm also recommended that the agency inspect domestic and foreign establishments with similar characteristics at a comparable frequency rate, in contrast to the current imbalance of far fewer overseas inspections than domestic site visits.



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