FDA 483 - Akorn, Inc. - April 08, 2022

During an inspection from March 28 to April 8, 2022, the FDA issued a Form 483 to Akorn, Inc., a sterile drug manufacturer in Decatur, IL. The inspection identified three primary observations indicating significant non-compliance with regulatory requirements. Firstly, the company failed to consistently follow procedures designed to prevent microbiological contamination of sterile drug products, as evidenced by air bubbles in bioburden testing plates, which could compromise results. Secondly, Akorn exhibited a systemic failure in thoroughly reviewing and investigating unexplained discrepancies, batch failures, and out-of-specification results. This included inadequate root cause analyses for container closure integrity test failures and a lack of investigations for various plate defects observed during monitoring. Numerous quality events (QEs) and corrective and preventive actions (CAPAs) were found to be deficient. Examples include insufficient CAPAs for documented human errors related to missing quality documentation, cancelled CAPAs without proper justification or evidence of completion (e.g., for OOS weight checks and computer time issues), and delayed or unaddressed actions within open CAPAs. Finally, the firm lacked comprehensive written procedures for production and process controls necessary to ensure the identity, strength, quality, and purity of its drug products. For instance, a specific setup procedure did not include instructions for the observed use of a zip-tie on filling nozzle tubes. These observations, made pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, require Akorn, Inc. to implement and document appropriate corrective actions in response to the FDA.