Copley Memorial Hospital IRB FDA Record
Copley Memorial Hospital IRB has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Copley Memorial Hospital IRB" is on file.
- Latest inspection
- Feb 10, 2020 · OAI
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 | 2 | 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 |
|---|---|---|---|---|
| Feb 10, 2020 | Aurora, IL | Devices | Official Action Indicated (OAI) | 3008488415 |
| Jan 13, 2011 | Aurora, IL | Devices | No Action Indicated (NAI) | 3008488415 |
- 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 3008488415 | Aurora, IL | 2 | Feb 10, 2020 |
Copley Memorial Hospital IRB and the FDA: common questions
Has Copley Memorial Hospital IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Copley Memorial Hospital 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 Copley Memorial Hospital IRB received an FDA Form 483?
FDA has not published a Form 483 for "Copley Memorial Hospital IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Copley Memorial Hospital IRB?
The most recent FDA inspection on file ended Feb 10, 2020 at Aurora, IL and was classified OAI. FDA has 2 inspections of Copley Memorial Hospital IRB on file, 1 of them classified OAI (official action indicated).
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