FDA Inspection
Thomas Jefferson University HospitalThomas Jefferson University Hospital – FDA Inspection, Jan 20, 2017
Record Details
This FDA Inspection record concerns Thomas Jefferson University Hospital, with an inspection on January 20, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · f84db673-8859-443e-af4a-61cb5e34b9af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998190
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.160(b)Required records
- 21 CFR 630.10(g)(1)Proof Of Identity
- 21 CFR 630.10(e)(2)Additional Medical Assessment Factors
- 21 CFR 630.10(g)(2)(ii)Donor"s Acknowledgment - Exculpatory language
- 21 CFR 630.10(g)(2)(ii)Donor's Acknowledgment - Exculpatory language
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Other FDA inspections of Thomas Jefferson University Hospital
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 18, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| December 18, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 1, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 17, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Thomas Jefferson University Hospital
- FDA Inspection 1293370 - 2025-09-26
- FDA Inspection 1204500 - 2023-04-18
- FDA Inspection 1118372 - 2019-12-18
- FDA Inspection 898311 - 2014-10-01
- FDA Inspection 803206 - 2012-10-17
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