FDA Inspection 876646 — General Hospital Corporation (The)
The FDA completed an inspection of General Hospital Corporation (The) on April 28, 2014 in Boston, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 28, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Boston, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15034 | 21 CFR 610.47(a)(1) | Review Records ID Previous Donations [Collecting Estab] |
| 15065 | 21 CFR 610.46(a)(1) | Review Records to ID Previous Donations [Collecting Estab] |
| 181 | 21 CFR 610.53(b) | Dating periods for licensed biological products |
| 205 | 21 CFR 640.3(f) | Donations in less than eight weeks |
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 9225 | 21 CFR 606.171 | Biological product deviation report |