# FDA 483 - Grifols Diagnostic Solutions Inc. - February 27, 2019

Source: https://www.globalkeysolutions.net/records/483/grifols-diagnostic-solutions-inc/b716cba7-6948-4db1-8eb0-6a099f4cbc96

> FDA 483 for Grifols Diagnostic Solutions Inc. on February 27, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Diagnostic Solutions Inc.
- Inspection Date: 2019-02-27
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: During an inspection, Grifols Diagnostic Solutions Inc. in Emeryville, CA, was cited for three observations. These included issues with software configuration preventing access to original chromatograms, manufacturing of a working seed stock not adhering to the approved BLA, and validation acceptance criteria for column use time limits not reflecting current practices.

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## Related Officers

- [CSO](https://www.globalkeysolutions.net/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)

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

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