FDA Inspection 1287038 — KAIGEN PHARMA CO.,LTD.
The FDA completed an inspection of KAIGEN PHARMA CO.,LTD. on September 26, 2025 in Otaru. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 26, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Otaru (Japan)