# FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - February 10, 2023

Source: https://www.globalkeysolutions.net/records/483/fujifilm-diosynth-biotechnologies-usa-inc/4195691b-fc0e-45b6-8d70-bbfc800e6672

> FDA 483 for FujiFilm Diosynth Biotechnologies U.S.A., Inc. on February 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FujiFilm Diosynth Biotechnologies U.S.A., Inc.
- Inspection Date: 2023-02-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Fujifilm Diosynth Biotechnologies USA, Inc. in Morrisville, NC, a drug substance manufacturer, revealed significant deficiencies in their quality system. Observations included the absence of a written quality agreement defining responsibilities for drug substance quality, a lack of established procedures for reporting biological product deviations, and insufficient studies to verify endotoxin clearance monitoring during purification.

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## Related Officers

- [Xiaoxiao Pan](https://www.globalkeysolutions.net/people/xiaoxiao-pan/68cacc02-fb13-4210-a330-61ab37eab1ae)
- [issuing_officer](https://www.globalkeysolutions.net/people/jee-y-chung/0736677f-9719-44dc-9dab-60b610ac1a0a)
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Company: https://www.globalkeysolutions.net/companies/fujifilm-diosynth-biotechnologies-usa-inc/44b7fa9f-848c-4e30-869e-12ddcfd848f8

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