News: Akorn receives warning from the FDA for cGMP violations
The U.S. FDA issued a warning letter to Akorn for violating the cGMP at the New Jersey manufacturing facility in Somerset. The letter as discussed by the Akorn on June 25th details the observation from Form 483 made by the FDA.
The major issue cited in the letter was the Quality System at the site, which seemed to lack in delivering the accuracy and integrity that further influences the safety, effectiveness, and quality of the drugs they manufacture. The other issues raised were regarding the defects from one lot of its ketorolac tromethamine ophthalmic solution products that “did not include a meaningful evaluation” and was inadequate.