The Story Behind DuPont’s Unprecedented Excipient Warning Letter And Tips On How To Avoid Another
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.
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Agency has increased its efforts to protect the US market from the diethylene glycol and ethylene glycol adulteration linked to hundreds of deaths in seven countries with testing, remote records requests, inspections, import alerts and more. Manufacturing quality compliance director Francis Godwin stresses importance of testing every container, while sharing tips for simplifying the task.
One in five of the drug GMP warning letters the US FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became a major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. The year also featured a pair of warning letters to excipient firms, one a Mexican glycerin supplier, and the other a unit of DuPont.
Foreign tablets, active pharmaceutical ingredient residues and failed line clearance plagued operations at repackers that received FDA warning letters in FY 2023.