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

Source: https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-texas-llc/3bc2271b-46ab-42e0-bc9f-51bb578fff61

> FDA 483 for FUJIFILM Diosynth Biotechnologies Texas, LLC on June 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: 2023-06-07
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of FUJIFILM Diosynth Biotechnologies Texas, LLC in College Station, Texas, a biological drug substance manufacturer, revealed significant deficiencies across multiple quality systems. Observations included inadequate quality control procedures, unvalidated analytical methods, insufficient process validation, and poor environmental monitoring. The firm also failed to thoroughly investigate discrepancies, maintain adequate written procedures, and ensure data integrity.

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## Related Officers

- [Laurinner Kuilan-Torres](https://www.keypedia.com/people/laurinner-kuilan-torres/1b1e14be-e55c-4fc5-b6b3-c6e62dc729e6)
- [Lindsey Brown](https://www.keypedia.com/people/lindsey-brown/ff47f714-146f-474e-a6b8-2cf14c67dd4f)

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321