FDA Inspection 1164710 — Wanzhu Hou, CMD, MD (CN)
The FDA completed an inspection of Wanzhu Hou, CMD, MD (CN) on Mar 17, 2022 in Rockville, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 17, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Rockville, MD (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7562 | 21 CFR 312.60 | Informed consent |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |