# FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - March 11, 2025

Source: https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-texas-llc/fc23b2a4-12b7-4de5-976a-6d3dc24ac571

> FDA 483 for FUJIFILM Diosynth Biotechnologies Texas, LLC on March 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUJIFILM Diosynth Biotechnologies Texas, LLC
- Inspection Date: 2025-03-11
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Fujifilm Diosynth Biotechnologies Texas, LLC, a drug substance manufacturer in College Station, TX, was cited for significant deficiencies across its manufacturing, quality control, and data management systems. Observations included inadequate controls for cross-contamination, deficient cleaning and environmental monitoring, unvalidated QC test methods, and a lack of proper controls for electronic data integrity. The firm also failed to follow its own SOPs for stability testing and contractor qualification, indicating systemic issues in maintaining a state of control.

## Related Documents

- [483 - 2021-08-31](https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-texas-llc/cadb1071-aeca-45aa-ac59-168d413ff72a)
- [EIR - 2021-08-31](https://www.keypedia.com/records/eir/fujifilm-diosynth-biotechnologies-texas-llc/c92805e5-2475-4997-9998-25747d671e72)
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- [483 - 2023-11-07](https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-texas-llc/77895ddb-3f0d-41f4-be7f-82f98a0b9e2a)

## Related Officers

- [Jie He](https://www.keypedia.com/people/jie-he/162aef4b-4b22-48e5-9a50-9b2e9684d589)
- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Ayyappan Rathakrishnan](https://www.keypedia.com/people/ayyappan-rathakrishnan/4f1e717b-5d46-4f94-83c8-59eff245cc44)
- [Yanyan Cao](https://www.keypedia.com/people/yanyan-cao/6b913005-9317-4f0d-9120-97fc29c53a3b)
- [Mercy Oyugi](https://www.keypedia.com/people/mercy-oyugi/9da8ebdc-a4c6-4666-9096-9a17f4edcf6c)

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

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9