# FDA 483 - Grifols Diagnostic Solutions Inc. - October 31, 2025

Source: https://www.keypedia.com/records/483/grifols-diagnostic-solutions-inc/530efa1d-b8c6-4edd-9813-13d4545ce18a

> FDA 483 for Grifols Diagnostic Solutions Inc. on October 31, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Diagnostic Solutions Inc.
- Inspection Date: 2025-10-31
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Grifols Diagnostic Solutions, Inc. in Emeryville, CA, revealed a significant issue regarding clinical investigator documentation. The firm failed to obtain a complete Form FDA-1572 before allowing an investigator to participate in a study. This lapse resulted in a clinical site conducting study activities with investigational product on donor specimens without proper documentation.

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## Related Officers

- [Cynthia J. Tsui](https://www.keypedia.com/people/cynthia-j-tsui/e02b5fd2-e90b-47a7-bbc2-e658f160c4ae)

Company: https://www.keypedia.com/companies/grifols-diagnostic-solutions-inc/367fc2ea-4212-40dc-828b-ea132f3f3206

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b