1. Pink Sheet

FDA GMP Warning Letters Review: Foreign Drug Product Firms Hit Hard On GMP Basics

 
• By Bowman Cox

Many of the 30 drug product firms that received FDA warning letters in 2016 were foreign cosmetics and hygiene manufacturers that appeared to need education on US GMP requirements. Another major focus in letters to drug product firms last year was sterility assurance in the US and abroad.

The US FDA last year challenged foreign cosmetics and hygiene firms to start following basic US drug GMP requirements for products that the agency regulates as drugs.

Overseas consumer products firms that appeared to have little familiarity with US good manufacturing practices requirements accounted for a surprising share of the drug

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