FDA Inspection 1328782 — Endovascular Engineering, Inc
The FDA completed an inspection of Endovascular Engineering, Inc on Jul 21, 2026 in Menlo Park, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 21, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Menlo Park, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14517 | 21 CFR 812.35(a)(1) | No approval for changes requiring prior approval |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |