FDA Inspection
NAVISWISS AGNAVISWISS AG – FDA Inspection, Jul 25, 2024
Record Details
This FDA Inspection record concerns NAVISWISS AG, with an inspection on July 25, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7fd975c4-19ad-4b6e-a8cc-06e489c5e188
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1244967
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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