FDA Inspection 1028255 — Mount Auburn Hospital Blood Bank
The FDA completed an inspection of Mount Auburn Hospital Blood Bank on September 29, 2017 in Cambridge, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
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 |