FDA Inspection 584551 — Javier O. Morales Ramirez, MD
The FDA completed an inspection of Javier O. Morales Ramirez, MD on May 22, 2009 in San Juan, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 22, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Juan, PR (United States)
Additional details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7527 | 21 CFR 312.62(a) | Unused drug disposition (investigator) |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7531 | 21 CFR 312.62(c) | Record retention |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |