# FDA 483 - DiAgam Societe Anonyme (S.A.) - December 18, 2025

Source: https://www.keypedia.com/records/483/diagam-societe-anonyme-sa/f601b967-760d-46df-a62a-d1e632648db5

> FDA 483 for DiAgam Societe Anonyme (S.A.) on December 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DiAgam Societe Anonyme (S.A.)
- Inspection Date: 2025-12-18
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Diagam Societe Anonyme (S.A.) in Ath, Belgium, revealed significant deficiencies in their manufacturing processes for Alpha2-Macroglobulin immunoturbidimetry IVD kits. The firm failed to adequately validate critical capping processes and analyzer testing, and operated equipment outside validated parameters. Additionally, procedures for equipment maintenance, finished device acceptance, and in-process product control were found to be inadequate.

## Related Documents

- [483 - 2020-03-01](https://www.keypedia.com/records/483/diagam-societe-anonyme-sa/00e48d67-3ea9-46ec-ae66-c42a6e5277c3)

## Related Officers

- [Naakesh N. Gomanie](https://www.keypedia.com/people/naakesh-n-gomanie/6fca201e-e851-40b8-9024-30cd5d89f2c2)

Company: https://www.keypedia.com/companies/diagam-societe-anonyme-sa/d43f46c8-549e-4683-a256-1582f0f8c361

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4