FDA Inspection 1329284 — COMPASS INNOVATIONS INC
The FDA completed an inspection of COMPASS INNOVATIONS INC on Aug 4, 2026 in Santa Clara, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 4, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Santa Clara, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |