US FDA Pressing Repackers To Disclose API Suppliers In Case Quality Issues Arise

The FDA's Francis Godwin tells Pink Sheet of progress battling supply chain obfuscation, which could allow marketing of adulterated drugs; Yino warning letter is latest salvo.  

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fda warnings are revealing suppliers • Source: Shutterstock

A warning letter the US Food and Drug Administration recently sent to Yino Inc. of Chongqing, China, is the latest in a series of actions the agency has taken to protect US patients and consumers from certain quality risks associated with opaque pharmaceutical supply chains.

Francis Godwin, director of the Office of Manufacturing Quality in the FDA’s Center for Drug Evaluation and Research, told the Pink Sheet that the effort appears to be making supply

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