FDA Inspection 596162 — Cooley Dickinson Hospital, Bb
The FDA completed an inspection of Cooley Dickinson Hospital, Bb on July 13, 2009 in Northampton, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 13, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Northampton, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 155 | 21 CFR 606.160(b) | Required records |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |
| 9256 | 21 CFR 610.41 | Donor Deferral |
| 9269 | 21 CFR 610.40(h) | Shipment/use of reactive units, units from deferred donors |