Nyxoah S.A. MilmortNovember 15, 2024

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

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Record Details

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.

Company: Nyxoah S.A. Milmort
Inspection Date: November 15, 2024
Product Type: Device
Office: Office of Inspections and Investigations
Person: Sarah A. Hassas (investigator)

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ID · a5018fbe-dd1a-4713-a3cd-7b500faf74bd