Santa Clara Valley Medical Center IRB FDA Record
- Latest inspection VAI · Jun 3, 2021
- No warning letters matched by name
Santa Clara Valley Medical Center IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Santa Clara Valley Medical Center IRB" is on file.
- Latest inspection
- Jun 3, 2021 · 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 | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 3, 2021 | San Jose, CA | Biologics | Voluntary Action Indicated (VAI) | 1000100855 |
| Apr 11, 2016 | San Jose, CA | Drugs | Voluntary Action Indicated (VAI) | 1000100855 |
| Sep 19, 2014 | San Jose, CA | Drugs | Official Action Indicated (OAI) | 1000100855 |
| Jul 17, 2009 | San Jose, CA | Drugs | No Action Indicated (NAI) | 1000100855 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000100855 | San Jose, CA | 4 | Jun 3, 2021 |
Santa Clara Valley Medical Center IRB and the FDA: common questions
Has Santa Clara Valley Medical Center IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Santa Clara Valley Medical Center IRB" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Santa Clara Valley Medical Center IRB received an FDA Form 483?
FDA has not published a Form 483 for "Santa Clara Valley Medical Center IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Santa Clara Valley Medical Center IRB?
The most recent FDA inspection on file ended Jun 3, 2021 at San Jose, CA and was classified VAI. FDA has 4 inspections of Santa Clara Valley Medical Center IRB on file, 1 of them classified OAI (official action indicated).
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