FDA Inspection 1330540 — Enterix, Inc.
The FDA completed an inspection of Enterix, Inc. on Aug 10, 2026 in Edison, NJ. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 10, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23212 | ISO 13485:2016 Clause 8.2.1 | Feedback process procedures not documented |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |