1028255
Mount Auburn Hospital Blood Bank — FEI 1270505
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Cambridge, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 18077 | 21 CFR 630.10(d)(2) | Donation interval |
| 18119 | 21 CFR 630.30(b)(2) | Unsuitable donation - defer testing |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |