FDA Inspection 668740 — Temple University Hospital - Jeanes Campus
The FDA completed an inspection of Temple University Hospital - Jeanes Campus on June 18, 2010 in Philadelphia, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 18, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |