FDA Inspection 978919 — Magstim Inc
The FDA completed an inspection of Magstim Inc on Jun 17, 2016 in Eugene, OR. 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
- Jun 17, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Eugene, OR (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |
| 2991 | 21 CFR 812.140(b)(1) | Sponsor correspondence records inadequate |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |