Akorn, Inc. – FDA EIR, Apr 8, 2022

An FDA surveillance inspection of Akorn, Inc., a sterile drug product manufacturer located in Decatur, IL, was conducted from March 28 to April 8, 2022. This inspection served as a follow-up to a previous Official Action Indicated (OAI) classification from a 2018 inspection and a subsequent 2019 Warning Letter regarding significant Good Manufacturing Practice deficiencies. The current inspection assessed the firm's adherence to regulatory frameworks, including 21 CFR Parts 210 and 211, and the Federal Food, Drug, and Cosmetic Act, under Compliance Program 7356.002 and 7356.002A. The inspection resulted in three significant observations documented on an FDA Form 483. Key issues identified were: a failure to initiate thorough investigations and implement adequate corrective and preventive actions; the presence of bubbles observed in critical materials utilized for pre-fill products; and deficiencies in written procedures for certain line set-up operations, specifically lacking instructions for using a particular tool on filling lines. The issuance of the FDA Form 483 indicates that Akorn, Inc. is required to address these observations promptly to restore and maintain compliance with regulatory standards.