FDA Enforcement Initiatives Raise Visibility Of Supply Chain GMP Issues
US FDA is issuing “90-day” decisional letters at a quickening pace, publishing the inspectional results within another 30 days, and copying sponsors on warning letters, among other steps, to call their attention to GMP problems in their supply chains.
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Happy New Year – or not! Firms inspected by US FDA since Oct. 1 will receive word within 90 days whether their facilities received passing – or failing – grades under timelines mandated by GDUFA II and incorporated into the agency's new Concept of Operations agreement, FDA officials tell FDLI meeting.
Some filling lines and API plants fared poorly in post-pandemic inspections, with shortfalls identified in sterility assurance and impurity control. Zhejiang Tianyu and System Kosmetik got warning letters. Alvotech, Cipla and Aurobindo got Form 483 reports posted on the FDA website.
Responses to FDA draft guidance suggest more promptness while also more elaborate processes for agency decision making based on remote methods. Questions include what’s voluntary, what’s mandatory, what can be decided remotely, and how to remotely move on from warning letters.