Akorn Receives FDA Warning Letter, Says It's Committed To Resolving Issues

Generic pharmaceuticals manufacturer Akorn, Inc. AKRX said Tuesday that it received a warning letter from the Food and Drug Administration related to the inspection of its Somerset, New Jersey manufacturing facility in July and August 2018.

The stock was down 1.27% at $4.67 at the time of publication Tuesday. 

Akorn said it is committed to the highest standards of quality and compliance and will continue to work collaboratively with the FDA to resolve issues addressed in the warning letter.

Benzinga reported in January that the company received an FDA warning letter related to a Decatur, Illinois manufacturing facility. 

The Lake Forest, Illinois-based company said it will respond to the FDA letter within the required 15 working days from the date of receipt. 

“Akorn is committed to resolving the warning letter in a comprehensive and effective manner,” CEO Douglas Boothe said in a statement. 

“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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