FDA Inspection 1296482 — Hirotaka Nagashima
The FDA completed an inspection of Hirotaka Nagashima on December 12, 2025 in Chuo. 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
- December 12, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Chuo (Japan)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |