FDA 483 - Unigen Inc.

An FDA inspection of Unigen Inc., a licensed biological manufacturer in Ibi District, Gifu, Japan, revealed significant deficiencies in its quality control unit, investigation procedures, and data management practices. The firm failed to follow written procedures, thoroughly review discrepancies, adequately investigate failures, and ensure data integrity, impacting the quality and control of its biological products. These issues indicate a systemic breakdown in their quality system.