FY 2015 Drug GMP Warning Letters Hit Compounders and Foreign Sites
This article was originally published in The Gold Sheet
FDA issued 42 GMP drug warning letters in FY 2015, a 6% reduction compared to the previous year. The agency’s enforcement efforts continue to focus on compounding pharmacies and foreign manufacturing sites, while data integrity lapses continue to grow and a UK MHRA inspector said that a different mindset is needed to resolve these problems.
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