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FDA GMP Warning Letters Review: Rate Soared In 2016 On Sterility And Data Integrity Concerns

Executive Summary

Poor data integrity at Asian API firms, poor quality programs at foreign OTC firms and poor sterility assurance at US compounding pharmacies were the main factors leading US FDA to issue 110 drug GMP warning letters in 2016, a huge increase from prior years. Article is first of four-part series in our annual analysis.

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