FDA Inspection 972742 — Stephen C. Jensik
The FDA completed an inspection of Stephen C. Jensik on Jun 9, 2016 in Chicago, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 9, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Chicago, IL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7531 | 21 CFR 312.62(c) | Record retention |