# FDA 483 - DiAgam Societe Anonyme (S.A.) - March 01, 2020

Source: https://www.keypedia.com/records/483/diagam-societe-anonyme-sa/00e48d67-3ea9-46ec-ae66-c42a6e5277c3

> FDA 483 for DiAgam Societe Anonyme (S.A.) on March 01, 2020. 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: 2020-03-01
- Product Type: device
- Office Name: International Compliance Team
- Summary: Diagam S.A. in Ghislenghien, Belgium, a manufacturer of Class II medical devices, was cited for six observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate design control, supplier management, device labeling, document control, and incoming product acceptance procedures. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

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

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