FDA Inspection
Infinite Biomedical TechnologiesInfinite Biomedical Technologies – FDA Inspection, Jul 30, 2026
Record Details
This FDA Inspection record concerns Infinite Biomedical Technologies, with an inspection on July 30, 2026, issued by the Center for Devices and Radiological Health.
- Inspection Date
- July 30, 2026
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ID · d2b968a0-e7b8-4cee-b5a3-09e915d4ad9e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1328694
- Project area
- Compliance: Devices
FDA Citations
4- ISO 13485:2016 Clause 8.5.2Corrective action not taken
- ISO 13485:2016 Clause 6.2(a)Resources for meeting regulatory and customer requirements not provided
- ISO 13485:2016 Clause 7.3.3Design and development inputs do not include all requirements
- ISO 13485:2016 Clause 6.1(b)Resources for meeting regulatory and customer requirements not provided
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Other FDA inspections of Infinite Biomedical Technologies
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 30, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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