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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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 international group will work on harmonizing scientific and technical standards for generic drugs, which could reduce duplication and development costs.
The Quality Lowdown: EU/Japan MRA, Field Alerts, Akorn, New Pfizer Plant, And The Answer Is Continuous Manufacturing
Japan and EU expand drug inspection agreement while rebuking Trump on trade; Pfizer invests tax cut in modular plant; FDA commissioner sells continuous manufacturing.