FDA Inspection 966652 — Hans Biomed Corporation
The FDA completed an inspection of Hans Biomed Corporation on March 31, 2016 in Yuseong District. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 31, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Yuseong District (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |