831058
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |