FDA Inspection 660288 — St Joseph's University Medical Center - Blood Bank
The FDA completed an inspection of St Joseph's University Medical Center - Blood Bank on May 5, 2010 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 5, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Paterson, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |