FDA Inspection 777003 — St Joseph's University Medical Center - Blood Bank
The FDA completed an inspection of St Joseph's University Medical Center - Blood Bank on Apr 16, 2012 in Paterson, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 16, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Paterson, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 32 | 21 CFR 606.20(c) | Exclusion of certain persons |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |