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Akorn Receives Warning Letter from FDA

Relates to the inspection of its Somerset, NJ manufacturing facility in July and August of 2018

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By: Kristin Brooks

Managing Editor, Contract Pharma

Akorn, Inc., a specialty generic pharmaceutical company, received a warning letter from the U.S. Food and Drug Administration (FDA) related to the inspection of its Somerset, NJ manufacturing facility in July and August 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 from receipt.

Douglas Boothe, Akorn’s president and chief executive officer, said, “Akorn is committed to resolving the warning letter in a comprehensive and effective manner. Earlier this year, Akorn launched a companywide action plan to improve the timing and effectiveness of our operations, quality systems and compliance enhancement initiatives, with an emphasis on transparency and quality. We believe the execution of this action plan, which has already begun to yield tangible results, will strengthen and further standardize our quality systems across the entire Akorn network.”

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