# FDA 483 - Unigen Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/unigen-inc/d7287792-dc3d-4323-8ae8-286c20190550

> FDA 483 for Unigen Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unigen Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/unigen-inc/eef4a797-0aad-472e-9352-ad660e96024a)

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [investigator](https://www.keypedia.com/people/anissa-cheung/28959f30-f1e9-43a0-bec8-efd114e8cec2)
- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)

Company: https://www.keypedia.com/companies/unigen-inc/55f10565-4316-44d5-802f-f7be056a8fa5

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd