# FDA 483 - FUJIFILM Diosynth Biotechnologies Texas, LLC - August 31, 2021

Source: https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-texas-llc/cadb1071-aeca-45aa-ac59-168d413ff72a

> FDA 483 for FUJIFILM Diosynth Biotechnologies Texas, LLC on August 31, 2021. 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: 2021-08-31
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: FUJIFILM Diosynth Biotechnologies Texas, LLC, a biologic drug substance manufacturer in College Station, TX, received a Form 483 with nine observations. The inspection revealed significant deficiencies including inadequate cross-contamination controls, insufficient batch contamination investigations, and a lack of equipment qualification data. Other issues involved failures in data integrity assessments, non-adherence to contamination control strategies, missing cell bank testing procedures, inaccurate inventory management, and deficiencies in work order trending and employee training.

## Related Documents

- [EIR - 2021-08-31](https://www.keypedia.com/records/eir/fujifilm-diosynth-biotechnologies-texas-llc/c92805e5-2475-4997-9998-25747d671e72)
- [483 - 2023-06-07](https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-texas-llc/3bc2271b-46ab-42e0-bc9f-51bb578fff61)
- [483 - 2023-11-07](https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-texas-llc/77895ddb-3f0d-41f4-be7f-82f98a0b9e2a)
- [483 - 2025-03-11](https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-texas-llc/fc23b2a4-12b7-4de5-976a-6d3dc24ac571)

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab