FDA Inspection 891633 — CXL-USA, LLC
The FDA completed an inspection of CXL-USA, LLC on August 19, 2014 in Rockville, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 19, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rockville, MD (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7411 | 21 CFR 312.53(c)(1) | Investigator statement (FDA 1572) |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7639 | 21 CFR 312.20(b) | Starting a study before IND is in effect |