FDA cracks down on China's Hengrui in scathing manufacturing write-up
Fierce Pharma
JUNE 6, 2024
When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. | In an eight-observation Form 483, the FDA chided Hengrui for a laundry list of manufacturing missteps, including poor contamination controls, subpar cleaning protocols, failure to promptly hand over documentation to inspectors and quality control shortfalls.
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