FDA Inspection 1130001 — Rafaelito S. Victoria, MD
The FDA completed an inspection of Rafaelito S. Victoria, MD on September 25, 2020 in La Palma, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- La Palma, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7518 | 21 CFR 312.64(d) | Financial info |
| 7520 | 21 CFR 312.64(b) | Safety reports |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7664 | 21 CFR 50.20 | Circumstances of obtaining consent |