FDA Inspection 998190 — Thomas Jefferson University Hospital
The FDA completed an inspection of Thomas Jefferson University Hospital on January 20, 2017 in Philadelphia, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 18082 | 21 CFR 630.10(e)(2) | Additional Medical Assessment Factors |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 18096 | 21 CFR 630.10(g)(2)(ii) | Donor's Acknowledgment - Exculpatory language |
| 78 | 21 CFR 606.100(c) | Record review prior to release |