Unigen Inc. – FDA 483

An FDA inspection of Unigen Inc. in Ibi District, Gifu, Japan, a biological drug substance manufacturer, revealed significant deficiencies in process validation, column re-use studies, and cleaning efficacy assessments. The inspection also identified inadequate procedures for preventing microbiological contamination, insufficient laboratory controls, and a lack of equipment qualification after shutdowns. These observations indicate a need for improved controls in critical manufacturing and quality control processes.