FDA GMP Warning Letters Review: API Supplier Warnings Surge On Data Integrity Concerns

 
• By Bowman Cox

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.

2016 Drug GMP Warning Letters By Facility Type, Day 2

A surge in drug good manufacturing practices warning letters to active pharmaceutical ingredient suppliers last year could spell trouble for the pharmaceutical industry.

The jump in warnings to API suppliers helped drive last year’s total for drug GMP warning letters to 110, a level not seen since 1995.

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