FDA Inspection 840650 — Prof. Johnny Mahlangu
The FDA completed an inspection of Prof. Johnny Mahlangu on July 18, 2013 in Johannesburg. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Johannesburg (South Africa)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |