FDA Inspection 1336996 — Trax Surgical, Inc.
The FDA completed an inspection of Trax Surgical, Inc. on Sep 23, 2026 in Stoughton, MA. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Stoughton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23216 | ISO 13485:2016 Clause 8.2.2 | Lack of documented justification for not investigating complaint(s) |
| 23261 | ISO 13485:2016 Clause 8.5.3 | Preventive action procedures not documented |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |