FDA Inspection
Infinite Biomedical TechnologiesInfinite Biomedical Technologies – FDA Inspection, Jul 30, 2019
Record Details
This FDA Inspection record concerns Infinite Biomedical Technologies, with an inspection on July 30, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 59a44de2-411d-4a4e-88ad-1c46fb024baa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098113
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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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 |
| June 10, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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