FDA GMP Warning Letters Review: API Supplier Warnings Surge On Data Integrity Concerns
US FDA’s drug GMP warning letters to API suppliers tripled in 2016, driven by data integrity findings in China and India and concerns about facilities and equipment maintenance. Trend could spell trouble for commercial production and launches. While there’s no turning back the clock on supply chain globalization, there’s no turning back the clock on FDA warning letters either.
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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.
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.
Zhejiang Medicine has become the latest major Chinese API firm to be hit with a US FDA warning letter amid stepped up oversight of production facilities in China by the US regulator, which has led to a string of similar actions this year alone. But efforts are now being made both by Chinese manufacturers and by authorities in the two countries to ensure adherence to international standards.