# FDA 483 - Grifols Diagnostic Solutions Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/grifols-diagnostic-solutions-inc/f2d357ba-8314-48be-8afc-384b8e4bd9f1

> FDA 483 for Grifols Diagnostic Solutions Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Diagnostic Solutions Inc.
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Grifols Diagnostics Solutions, Inc. in Emeryville, CA, was cited for multiple deficiencies related to complaint handling, investigation procedures, and product quality during an inspection of its licensed antigen manufacturing and IVD complaint/distribution operations. The firm failed to properly classify and escalate complaints, notify license holders of potential reportable events, and ensure adequate documentation and evaluation in investigations. These issues indicate a lack of robust quality system controls for managing product deviations and complaints.

## Related Documents

- [483 - 2019-02-27](https://www.keypedia.com/records/483/grifols-diagnostic-solutions-inc/b716cba7-6948-4db1-8eb0-6a099f4cbc96)
- [483 - 2024-12-13](https://www.keypedia.com/records/483/grifols-diagnostic-solutions-inc/90f14ba3-b686-4c21-8388-218bf1ace37d)

## Related Officers

- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1