FDA Inspection 1286616 — Vascular Solutions, LLC (A Subsidiary Of Teleflex)
The FDA completed an inspection of Vascular Solutions, LLC (A Subsidiary Of Teleflex) on Oct 10, 2025 in Maple Grove, MN. 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
- Oct 10, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Maple Grove, MN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |
| 3049 | 21 CFR 812.150(b)(5) | Sponsor progress reports for significant risk study |