483
Unigen Inc.FDA 483 - Unigen Inc.
Record Details
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.
- Company
- Unigen Inc.
- Product Type
- Biologics
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