FDA Inspection 1315766 — Enterra Medical, Inc.
The FDA completed an inspection of Enterra Medical, Inc. on May 4, 2026 in Minneapolis, MN. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 4, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23087 | ISO 13485:2016 Clause 7.1 | Product realization risk management processes not documented |
| 23134 | ISO 13485:2016 Clause 7.3.9 | Review of design and development do not include evaluation of change effects |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |