FDA Inspection 1336296 — Control Bionics
The FDA completed an inspection of Control Bionics on Sep 18, 2026 in Cincinnati, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 18, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cincinnati, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23028 | ISO 13485:2016 Clause 4.1.6 | QMS software not validated prior to use or changes |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |