FDA 483 - Akorn, Inc. - June 30, 2009

During an FDA inspection from June 1 to June 30, 2009, Akorn, Inc., a drug manufacturer in Decatur, IL, received a Form FDA 483 citing significant observations regarding its quality control and manufacturing processes. The primary concern, noted as a repeat observation, was the company's failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results, particularly concerning foreign matter rejects in its Fluorescein Injection, USP. The firm initiated numerous OOS investigations but did not perform a global investigation to identify actual root causes, implement effective corrective actions, or prevent ongoing occurrences, despite changing stoppers. Management reviews and quality oversight meetings also failed to adequately evaluate these persistent foreign matter issues. Furthermore, laboratory controls were found deficient. Akorn amended foreign matter specifications for Fluorescein Injection based solely on historical data, lacking scientific justification. There were no written procedures detailing how rejected vials with foreign matter should be examined. Critically, the microbiology department failed to validate individual lots of Tryptic Soy Agar rodac plates used for environmental monitoring from 2003 to 2008. These plates did not support the growth of Clostridium sporogenes, a pathogenic anaerobic organism, thus compromising the firm's ability to assure sterile manufacturing environments. The document also noted inadequate validation of the sterilization process, specifically for Media Fill Validation. These observations indicate non-adherence to regulatory requirements for robust quality systems and highlight the need for comprehensive corrective and preventive actions to ensure product quality and patient safety.