The Quality Lowdown: EU/Japan MRA, Field Alerts, Akorn, New Pfizer Plant, And The Answer Is Continuous Manufacturing
Executive Summary
Japan and EU expand drug inspection agreement while rebuking Trump on trade; Pfizer invests tax cut in modular plant; FDA commissioner sells continuous manufacturing.
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Akorn has been hit with its second warning letter this year, this time for similar issues at a different site, where the US FDA found the firm failed to adequately address problems with impurities and bottle defects. The Akorn letter may also be symptomatic of a larger problem being seen by the agency in the growing number of faulty root cause investigations.
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