University Of Virginia Health System FDA Inspection Record
University Of Virginia Health System is an FDA-inspected facility (FEI 1172512) located in Charlottesville, VA, US. RegDataLab tracks 7 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Jun 12, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (3 VAI, 4 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 12, 2026 | Voluntary Action Indicated (VAI) | Methods of component preparation (21 CFR 606.100(b)(6)) |
| Sep 12, 2024 | Voluntary Action Indicated (VAI) | Procedures to maintain records of emergency transfusions (21 CFR 606.151(e)) Equipment observed, standardized, calibrated (21 CFR 606.60(a)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) |
| May 13, 2022 | No Action Indicated (NAI) | No citations listed |
| Apr 26, 2019 | No Action Indicated (NAI) | No citations listed |
| Jun 23, 2017 | No Action Indicated (NAI) | No citations listed |
| Mar 15, 2012 | Voluntary Action Indicated (VAI) | Concurrent documentation (21 CFR 606.160(a)(1)) Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b)) Thorough investigations (21 CFR 606.100(c)) |
| Jul 14, 2010 | No Action Indicated (NAI) | No citations listed |
FDA record score
10 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
3 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Jun 12, 2026 | 6 x 1 | 6 |
| Inspection classified VAI | Sep 12, 2024 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Mar 15, 2012 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- University Of Virginia Health System
- Location
- Charlottesville, VA (US)
- Source
- inspections