# FDA 483 - Grifols Diagnostic Solutions Inc. - December 13, 2024

Source: https://www.globalkeysolutions.net/records/483/grifols-diagnostic-solutions-inc/90f14ba3-b686-4c21-8388-218bf1ace37d

> FDA 483 for Grifols Diagnostic Solutions Inc. on December 13, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Diagnostic Solutions Inc.
- Inspection Date: 2024-12-13
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Grifols Diagnostic Solutions Inc. in Emeryville, CA, a licensed antigen component manufacturer for IVDs, revealed significant deficiencies in process validation. The firm failed to appropriately validate the manufacturing process for licensed antigen HCV c100-3, opting for an inadequate verification approach. Additionally, the firm did not conduct required trend analyses of process data across all antigen types to ensure manufacturing processes are in a qualified state.

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- [483 - 2019-02-27](https://www.globalkeysolutions.net/records/483/grifols-diagnostic-solutions-inc/b716cba7-6948-4db1-8eb0-6a099f4cbc96)

## Related Officers

- [Nisha C. Patel](https://www.globalkeysolutions.net/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)
- [Gene D. Arcy](https://www.globalkeysolutions.net/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df