FDA Inspection
COMPANION SPINE FRANCE SASCOMPANION SPINE FRANCE SAS – FDA Inspection, May 15, 2025
Record Details
This FDA Inspection record concerns COMPANION SPINE FRANCE SAS, with an inspection on May 15, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- COMPANION SPINE FRANCE SAS
- Inspection Date
- May 15, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 5b4dd9a2-944f-4c33-bd47-6f4387a2149f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1269669
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.75(a)Documentation
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