Amita Health IRB FDA Record
- Latest inspection NAI · Aug 23, 2018
- No warning letters matched by name
Amita Health IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Amita Health IRB" is on file.
- Latest inspection
- Aug 23, 2018 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 4 | Nov 14, 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 |
|---|---|---|---|---|
| Aug 23, 2018 | Elk Grove Village, IL | Drugs | No Action Indicated (NAI) | 3014669549 |
| Jun 23, 2015 | Elk Grove Village, IL | Devices | No Action Indicated (NAI) | 3014669549 |
| Dec 12, 2013 | Elk Grove Village, IL | Devices | Official Action Indicated (OAI) | 3014669549 |
| Aug 17, 2009 | Elk Grove Village, IL | Devices | No Action Indicated (NAI) | 3014669549 |
- 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 3014669549 | Elk Grove Village, IL | 4 | Aug 23, 2018 |
Amita Health IRB and the FDA: common questions
Has Amita Health IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Amita 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 Amita Health IRB received an FDA Form 483?
FDA has not published a Form 483 for "Amita Health IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Amita Health IRB?
The most recent FDA inspection on file ended Aug 23, 2018 at Elk Grove Village, IL and was classified NAI. FDA has 4 inspections of Amita Health IRB on file, 1 of them classified OAI (official action indicated).
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