1096052
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 11, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rockville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 18134 | 21 CFR 640.21(g) | Informed consent |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |