# FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - November 07, 2023

Source: https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-texas-llc/77895ddb-3f0d-41f4-be7f-82f98a0b9e2a

> FDA 483 for FUJIFILM Diosynth Biotechnologies Texas, LLC on November 07, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUJIFILM Diosynth Biotechnologies Texas, LLC
- Inspection Date: 2023-11-07
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Fujifilm Diosynth Biotechnologies Texas, LLC, a monoclonal antibody manufacturer in College Station, TX, was inspected and found to have significant deficiencies across multiple areas. These include widespread failures to follow or establish adequate procedures, lack of validation for critical manufacturing processes and storage conditions, inadequate data integrity controls, and issues with material management leading to contamination.

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## Related Officers

- [Emine GuvenMaiorov](https://www.keypedia.com/people/emine-guvenmaiorov/00186865-3b56-4115-8c4b-cea8072a314b)
- [Jun Liu](https://www.keypedia.com/people/jun-liu/39e5d6f3-32fd-426f-880d-3d840a9faed2)
- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/fujifilm-diosynth-biotechnologies-texas-llc/5411232a-c284-4b0d-b955-09e32761748f

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