Unigen Inc. – FDA 483, Mar 9, 2023

During an FDA inspection conducted from March 2-9, 2023, Unigen Inc., a licensed biological manufacturer in Ibi District, Gifu, Japan, received several observations highlighting deficiencies in its operations. The inspection revealed significant concerns regarding the company's adherence to Current Good Manufacturing Practices. Key issues included inadequate quality control procedures, such as insufficient studies for column re-use, untimely revisions of process limits, and failure to properly evaluate manufacturing deviations or the use of compromised equipment like a cracked resin column. There was also a lack of timely reporting of critical changes to the Market Approval Holder and incomplete change control processes. Furthermore, Unigen Inc. failed to thoroughly investigate unexplained discrepancies and batch failures, with recurring issues like foreign matter in raw materials and persistent deviations in product specifications lacking comprehensive root cause analysis and corrective actions. Significant concerns were also raised about data integrity, with multiple instances of lost or unbacked-up critical manufacturing and quality control data due to system failures. Unigen Inc. is expected to address these observations to demonstrate compliance with regulatory standards for biological product manufacturing.