Following a more than one-month inspection last summer, the U.S. FDA this week released a warning letter for Akorn’s Somerset, New Jersey manufacturing facility due to cGMP violations. The warning letter issued June 13th and discussed by Akorn on June 25th, echoes some of the observations made by the FDA in a Form 483 for the site last November. The FDA specifically raises concerns with the site’s quality system, which “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.” Akorn’s data integrity issues led to the collapse of the merger agreement between Akorn and Fresenius Kabi. Learn More