FDA Inspection 1305474 — SurgiSmoke Solutions
The FDA completed an inspection of SurgiSmoke Solutions on February 23, 2026 in Saint Paul, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23125 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not complete prior to release of product |
| 23234 | ISO 13485:2016 Clause 8.2.6 | Product release and delivery proceeded prior to planned agreements completed |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 23273 | ISO 13485:2016 Clause 5.4.2(b) | Integrity of the QMS not maintained |