FDA Inspection
Control BionicsControl Bionics – FDA Inspection, Sep 18, 2026
Record Details
This FDA Inspection record concerns Control Bionics, with an inspection on September 18, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Control Bionics
- Inspection Date
- September 18, 2026
- Product Type
- Devices
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ID · 81d942e7-9ddf-4dda-b418-a80bfb7790ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1336296
- Project area
- Compliance: Devices
FDA Citations
2- ISO 13485:2016 Clause 4.1.6QMS software not validated prior to use or changes
- ISO 13485:2016 Clause 7.1Criteria for the evaluation and selection of suppliers not established
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Other FDA inspections of Control Bionics
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 8, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 1, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Control Bionics
- FDA Inspection 1207781 - 2023-06-06
- FDA Inspection 1122520 - 2020-02-27
- FDA Inspection 985365 - 2016-09-08
- FDA Inspection 669901 - 2010-07-01
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