# FDA 483 - Nyxoah S.A. Milmort - November 15, 2024

Source: https://www.globalkeysolutions.net/records/483/nyxoah-sa-milmort/a5018fbe-dd1a-4713-a3cd-7b500faf74bd

> FDA 483 for Nyxoah S.A. Milmort on November 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nyxoah S.A. Milmort
- Inspection Date: 2024-11-15
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Nyxoah S.A. Milmort, a medical device manufacturer, identified a significant deficiency regarding the documentation of process validation and equipment qualification. The firm failed to adequately document these critical activities, indicating a potential weakness in their quality system. This suggests a moderate severity issue related to ensuring product quality and safety.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/nyxoah-sa-milmort/bc1a5ce2-7a6f-466e-96fd-798979dc67f9

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8