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Warnings Up As FDA Trims Its List Of Uninspected OTC Drug Manufacturers

Executive Summary

Hundreds of foreign OTC drug firms marketing products in US had not been inspected for GMP compliance before FDA Safety and Innovation Act of 2012 pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and January 2018, 25% received "official action indicated" inspection results, prompting warning letters and import alerts.


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