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

 
• By Bowman Cox

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.

2016 Drug GMP Warning Letters By Facility Type, Day 1

US FDA warning letters related to good manufacturing practices more than doubled in 2016 as the agency continued to crack down on a lack of sterility assurance in domestic pharmacy compounding and a lack of data integrity in foreign active pharmaceutical ingredient manufacturing, and addressed a lack of basic GMP compliance among foreign over-the-counter drug manufacturers.

FDA issued 110 drug GMP warning letters in calendar year 2016, matching a record set in fiscal year 1995 (Also see "GMP warning letters issued by FDA in FY...

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