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

 
• By Bowman Cox

One in five drug GMP warning letters FDA issued in 2022 raised supply chain concerns. Active pharmaceutical ingredient distribution became major focal point as agency checked opioid and alcohol-based hand sanitizer supply chains. 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
• Source: Shutterstock

The US Food and Drug Administration emphasized pharmaceutical supply chain transparency in its compliance program in 2022, 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 an

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New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
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Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
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More from Policy & Regulation

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