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Akorn Passes FDA Lyo-PAI/cGMP Inspection

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Akorn, Inc. has received a satisfactory inspection from the FDA as part of a pre-approval inspection of the company’s lyophilization facilities in Decatur, IL. Akorn had cGMP issues in the past, but the recent inspection led the Chicago office of CDER to conclude that Akorn’s responses to the problems are acceptable. As a result of the inspection, Akorn is now eligible for pending product approvals in its ophthalmic, ampoule, liquid vial and lyophilization production filling suite...

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