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Warning Letters Special Report: What Worried The FDA Most About Pharmaceutical Supply Chains

 
• By Bowman Cox

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.  

2022 Warning Letters Special Report
what went into the apis and excipients? • Source: Shutterstock

The US Food and Drug Administration emphasized pharmaceutical supply chain transparency in its compliance program last year, and it showed in the warning letters the agency issued.

Supply chain concerns were raised in 20% of the drug good manufacturing practices warning letters issued in 2022, according to this final installment of the Pink Sheet‘s in-depth review of warning letters and

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