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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How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution
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.
Warning Letters Special Report: What Worried The FDA Most About Pharmaceutical Supply Chains
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.
US FDA Balances Urgent Need For Platinum Chemotherapies Against Intas Plant’s Quality Failures
As politicians demand help for cancer-ridden constituents, the agency allows Indian plant that flunked inspection to resume exporting batches of cisplatin and carboplatin to the US, but only after passing independent 45-day batch certification reviews.