FDA Inspection 668085 — Immunovative Clinical Research, Inc.
The FDA completed an inspection of Immunovative Clinical Research, Inc. on June 10, 2010 in Carlsbad, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 10, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Carlsbad, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7480 | 21 CFR 312.50 | Ensuring compliance with plan and protocol |