FDA Inspection 662484 — Vascular Solutions, LLC (A Subsidiary of Teleflex)
The FDA completed an inspection of Vascular Solutions, LLC (A Subsidiary of Teleflex) on May 10, 2010 in Maple Grove, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2010
- Fiscal Year
- 2010
- 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 |
| 2935 | 21 CFR 812.43(b) | Sponsor shipped devices to unqualified person(s) |
| 3048 | 21 CFR 812.150(b)(5) | Sponsor progress reports for non-significant risk study |