Valley Health/Winchester Medical Center IRB FDA Record
- Latest inspection VAI · Aug 9, 2022
- Last warning letter 2013
Valley Health/Winchester Medical Center IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Valley Health/Winchester Medical Center IRB, the most recent on May 9, 2013.
- Latest inspection
- Aug 9, 2022 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 4 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Valley Health/Winchester Medical Center IRB FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| May 9, 2013 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 9, 2022 | Winchester, VA | Biologics | Voluntary Action Indicated (VAI) | 1121588 |
| Apr 28, 2015 | Winchester, VA | Devices | No Action Indicated (NAI) | 1121588 |
| Feb 1, 2013 | Winchester, VA | Devices | Official Action Indicated (OAI) | 1121588 |
| Nov 12, 2008 | Winchester, VA | Devices | Voluntary Action Indicated (VAI) | 1121588 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Valley Health/Winchester Medical Center IRB: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1121588 | Winchester, VA | 4 | Aug 9, 2022 |
Valley Health/Winchester Medical Center IRB and the FDA: common questions
Has Valley Health/Winchester Medical Center IRB received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Valley Health/Winchester Medical Center IRB. The most recent is dated May 9, 2013.
Has Valley Health/Winchester Medical Center IRB received an FDA Form 483?
FDA has not published a Form 483 for "Valley Health/Winchester Medical Center IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Valley Health/Winchester Medical Center IRB?
The most recent FDA inspection on file ended Aug 9, 2022 at Winchester, VA and was classified VAI. FDA has 4 inspections of Valley Health/Winchester Medical Center IRB on file, 1 of them classified OAI (official action indicated).
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