National Jewish Health IRB FDA Record
- Latest inspection NAI · Oct 28, 2019
- No warning letters matched by name
National Jewish Health IRB has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "National Jewish Health IRB" is on file.
- Latest inspection
- Oct 28, 2019 · NAI
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 | 3 | 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 |
|---|---|---|---|---|
| Oct 28, 2019 | Denver, CO | Drugs | No Action Indicated (NAI) | 1718797 |
| May 28, 2014 | Denver, CO | Drugs | No Action Indicated (NAI) | 1718797 |
| Aug 28, 2009 | Denver, CO | Drugs | No Action Indicated (NAI) | 1718797 |
- 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 1718797 | Denver, CO | 3 | Oct 28, 2019 |
National Jewish Health IRB and the FDA: common questions
Has National Jewish Health IRB received an FDA warning letter?
No FDA warning letter addressed to the name "National Jewish Health 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 National Jewish Health IRB received an FDA Form 483?
FDA has not published a Form 483 for "National Jewish Health IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect National Jewish Health IRB?
The most recent FDA inspection on file ended Oct 28, 2019 at Denver, CO and was classified NAI. FDA has 3 inspections of National Jewish Health IRB on file.
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