FDA Inspection
Orchid Orthopedics Switzerland GmbHOrchid Orthopedics Switzerland GmbH – FDA Inspection, Sep 4, 2025
Record Details
This FDA Inspection record concerns Orchid Orthopedics Switzerland GmbH, with an inspection on September 4, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 4, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 9bb5514a-4208-4e97-bf52-e27a479f4cb2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1281107
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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