FDA Inspection 1308290 — Inmedix, Inc.
The FDA completed an inspection of Inmedix, Inc. on Mar 20, 2026 in Normandy Park, WA. 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
- Mar 20, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Normandy Park, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23119 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not performed as planned |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |