FDA Inspection
InfoBionic, Inc.InfoBionic, Inc. – FDA Inspection, Apr 10, 2019
Record Details
This FDA Inspection record concerns InfoBionic, Inc., with an inspection on April 10, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6a7ac35e-65eb-4746-8edb-fad7dd913be3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1085891
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - Risk analysis
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Other FDA inspections of InfoBionic, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for InfoBionic, Inc.
- FDA Inspection 1194164 - 2022-11-17
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