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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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FDA Warning Letter Hits Akorn’s Subpar Root Cause Investigations

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.  

The Quality Lowdown: Cadmium, Quality Metrics, Heparin Testing And Continuous Manufacturing

ICH relaxing a new limit for inhaled cadmium in drugs; FDA relaxes timeline for quality metrics site visit invitations; US FDA looks for heparin test to sort the porcine from the bovine and ovine; and universities win FDA grants for research into continuous pharmaceutical manufacturing.

Why Data Integrity Concerns Led Fresenius To Back Away From Akorn Deal

Tipped off by whistleblower, Fresenius reviewed data integrity audits that led it to back away from plans to acquire Akorn, firm tells court. It’s a case with lessons for any pharmaceutical company that wants to ensure its own data integrity – and that of its business partners.

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