# FDA 483 - DIAGAST - April 19, 2024

Source: https://www.keypedia.com/records/483/diagast/67f5c92e-29c7-41e9-a8ad-751922764c72

> FDA 483 for DIAGAST on April 19, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DIAGAST
- Inspection Date: 2024-04-19
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Diagast, a Biologics IVD Manufacturer in Loos, France, was cited for multiple significant quality system deficiencies during an FDA inspection. Observations included failures in Medical Device Reporting (MDR) submission and procedures, inadequate risk analysis for blood grouping reagents, and insufficient control over storage area temperature excursions. The firm also failed to document biological deviation reports and in-process quality control activities.

## Related Officers

- [Elias N. Paz Alonzo](https://www.keypedia.com/people/elias-n-paz-alonzo/723c0877-512c-49c2-9021-067175917c66)
- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [investigator](https://www.keypedia.com/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.keypedia.com/companies/diagast/c0e0edce-1abe-473a-9127-8abb20d191a6

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321