FDA Inspection
GETSET SURGICAL SAGETSET SURGICAL SA – FDA Inspection, Nov 6, 2025
Record Details
This FDA Inspection record concerns GETSET SURGICAL SA, with an inspection on November 6, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · a85ff21d-920c-44d3-861d-5b8f19a133f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1291076
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
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