FDA Inspection 1302738 — NDS Surgical Imaging LLC
The FDA completed an inspection of NDS Surgical Imaging LLC on February 13, 2026 in Sarasota, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sarasota, FL (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 |