FDA Inspection
University Medical Center Transfusion ServiceUniversity Medical Center Transfusion Service – FDA Inspection, Jul 23, 2019
Record Details
This FDA Inspection record concerns University Medical Center Transfusion Service, with an inspection on July 23, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 23, 2019
- Product Type
- Biologics
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ID · a31c268c-6a98-42eb-bd9f-8c79bc2bfcb7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097242
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.160(a)(1)Concurrent documentation
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Other FDA inspections of University Medical Center Transfusion Service
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2024 | Not classified | Dallas District Office | |
| February 28, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 20, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 10, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 8, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for University Medical Center Transfusion Service
- FDA Inspection 1251192 - 2024-09-26
- FDA Inspection 1019821 - 2017-02-28
- FDA Inspection 925783 - 2015-04-20
- FDA Inspection 813366 - 2013-01-10
- FDA Inspection 716343 - 2011-03-08
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