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Akorn Receives FDA Warning Letter

Akorn is working collaboratively with the FDA to resolve all issues related to an inspection of its Decatur, IL manufacturing facility

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By: Kristin Brooks

Managing Editor, Contract Pharma

Akorn, Inc., a specialty generic pharmaceutical company, has received a warning letter, dated January 4, from the U.S. FDA related to an inspection of its Decatur, IL manufacturing facility in April and May of 2018. 

Akorn is working collaboratively with the FDA to resolve all issues addressed in the warning letter. The Company will respond to the FDA letter within the required 15 working days.

The company is confident in the quality of the products manufactured at the Decatur facility and expects to continue production at the plant.

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