FDA Inspection 1282278 — Hans Biomed Corporation
The FDA completed an inspection of Hans Biomed Corporation on Sep 12, 2025 in Yuseong District. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 12, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Yuseong District (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |