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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, “...

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