FDA Inspection 680312 — Anulex Technologies Inc
The FDA completed an inspection of Anulex Technologies Inc on September 22, 2010 in Eden Prairie, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Eden Prairie, MN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2910 | 21 CFR 812.7(a) | Promotion or test marketing |
| 2924 | 21 CFR 812.20(a)(2) | Initiation of study prior to FDA IDE approval |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |