FDA Inspection 1308324 — Alejandra M.L. Romeo
The FDA completed an inspection of Alejandra M.L. Romeo on March 20, 2026 in Ciudad Autonoma Buenos Aires. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 20, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Ciudad Autonoma Buenos Aires (Argentina)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |