FDA Inspection 982550 — Jerry R Mendell MD
The FDA completed an inspection of Jerry R Mendell MD on August 19, 2016 in Columbus, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Columbus, OH (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7552 | 21 CFR 312.66 | Changes in research |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |