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The Story Behind DuPont’s Unprecedented Excipient Warning Letter And Tips On How To Avoid Another

 
• By Bowman Cox

Insights from the FDA’s Francis Godwin on how the agency came to issue a warning letter to a DuPont excipient plant and how the normally under-the-radar sector can ensure GMP compliance.

Running away from complaints
no escape from complaints • Source: Shutterstock

An official with the US Food and Drug Administration’s Center for Drug Evaluation and Research recently shared insights with pharmaceutical excipient manufacturers on the agency’s compliance expectations for the sector in the wake of an unprecedented warning letter it sent an excipient firm in December.

The

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