FDA Inspection
In2Bones, SASIn2Bones, SAS – FDA Inspection, Sep 4, 2025
Record Details
This FDA Inspection record concerns In2Bones, SAS, with an inspection on September 4, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 4ec53cda-68a8-4916-8d5b-75e001a9ce96
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1280847
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation - UDI
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of In2Bones, SAS
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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