FDA Inspection 1341670 — Aurident Inc
The FDA completed an inspection of Aurident Inc on Oct 15, 2026 in Fullerton, CA. 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
- Oct 15, 2026
- Fiscal Year
- 2027
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fullerton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23061 | ISO 13485:2016 Clause 5.6.1 | QMS not reviewed by top management at documented planned intervals |
| 23137 | ISO 13485:2016 Clause 7.3.10 | Design and development file does not include or reference required records |
| 23142 | ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored |