FDA GMP Warning Letters Review: Rate Soared In 2016 On Sterility And Data Integrity Concerns
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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The spate of recent warning letters going to foreign pharmaceutical manufacturers continues as two Asian firms get into trouble for GMP violations: Firson Co. in South Korea and Wuxi Medical Instrument Factory in China.
A top FDA compliance official warns the generic drug industry of a “revival” of data integrity fraud as a number of brand-name drugs go off patent and companies rush to be the first to file.
Mutual recognition agreement enables US and European authorities to redirect inspectional resources to China and India. The result could be more warning letters and other actions unless global companies strengthen oversight of ingredient suppliers and contract manufacturers in Asia, current and former FDA officials say.