FDA Inspection 1216052 — Hans Biomed Corporation
The FDA completed an inspection of Hans Biomed Corporation on Aug 25, 2023 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 25, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Yuseong District (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 12357 | 21 CFR 1271.195(a)(1) | Temperature and humidity controls |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12365 | 21 CFR 1271.195(d) | Documentation not maintained |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |