FDA Inspection
BAND CONNECTBAND CONNECT – FDA Inspection, Dec 12, 2025
Record Details
This FDA Inspection record concerns BAND CONNECT, with an inspection on December 12, 2025, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · d7be3e2d-4d01-4da4-a951-ee498bfb937b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1294922
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
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