FDA Inspection 1254663 — Center for Immunology Science, LLC
The FDA completed an inspection of Center for Immunology Science, LLC on November 20, 2024 in Los Angeles, 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: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 20, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Los Angeles, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |