FDA Inspection
Infinite Biomedical TechnologiesInfinite Biomedical Technologies – FDA Inspection, Jun 10, 2022
Record Details
This FDA Inspection record concerns Infinite Biomedical Technologies, with an inspection on June 10, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 10, 2022
- Product Type
- Devices
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ID · 3b7c56dd-cecb-4a2d-a43b-ec9d4f0b8359
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1171579
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Infinite Biomedical Technologies
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2026 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 30, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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