FDA Inspection
University Of Virginia Health SystemUniversity Of Virginia Health System – FDA Inspection, Sep 12, 2024
Record Details
This FDA Inspection record concerns University Of Virginia Health System, with an inspection on September 12, 2024, issued by the Baltimore District Office, covering biologics.
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ID · f2d85d9b-0e6c-4ad1-a9fb-c669c162551d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249455
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of University Of Virginia Health System
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2026 | VAI | Baltimore District Office | Blood and Blood Products |
| May 13, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 26, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 23, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 15, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for University Of Virginia Health System
- FDA Inspection 1321822 - 2026-06-12
- FDA Inspection 1170707 - 2022-05-13
- FDA Inspection 1094453 - 2019-04-26
- FDA Inspection 1020992 - 2017-06-23
- FDA Inspection 774771 - 2012-03-15
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