FDA Inspection 676437 — NAMSA
The FDA completed an inspection of NAMSA on Sep 3, 2010 in Minneapolis, MN. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 3, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Minneapolis, MN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2935 | 21 CFR 812.43(b) | Sponsor shipped devices to unqualified person(s) |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |