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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 suites in the Decatur site.

Arthur S. Przybyl, Akorn’s president and chief executive officer stated, “We are pleased to announce the results from the latest FDA inspection of our Decatur, IL manufacturing facility. Akorn remains committed to maintaining a comprehensive and robust quality system in order to remain in compliance with current good manufacturing practice regulations. This positive result is a significant event for Akorn. The results of this recent inspection allow us to commercialize our lyophilization manufacturing capabilities. We believe a shortage of lyophilization manufacturing capacity still exists in the market place.”

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