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Akorn Completes FDA Re-inspection of Decatur Facility

Verifies the implementation and effectiveness of responses to previous observations

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By: Kristin Brooks

Managing Editor, Contract Pharma

Akorn, Inc. has successfully completed a re-inspection by the U.S. FDA conducted of its Decatur, IL manufacturing facility from December 5-9, with no Form 483 observations.  
 
The re-inspection was conducted to verify the implementation and effectiveness of Akorn’s responses to the observations from the June 2016 FDA inspection.
 
Akorn is a specialty generic pharma company that develops, manufactures and markets multisource and branded pharmaceuticals. Akorn also has manufacturing facilities in Somerset, NJ; Amityville, NY; Hettlingen, Switzerland and Paonta Sahib, India that manufacture ophthalmic, injectable and specialty sterile and non-sterile pharmaceuticals. 

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