Duke University Health System IRB FDA Record
- Latest inspection NAI · Sep 11, 2025
- No warning letters matched by name
Duke University Health System IRB has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Duke University Health System IRB" is on file.
- Latest inspection
- Sep 11, 2025 · 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 | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Duke University Health System IRB: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
Reviewing Duke University Health System IRB as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Duke University Health System IRB yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 11, 2025 | Durham, NC | Devices | No Action Indicated (NAI) | 1045114 |
| Mar 1, 2019 | Durham, NC | Devices | No Action Indicated (NAI) | 1045114 |
| Sep 1, 2016 | Durham, NC | Devices | No Action Indicated (NAI) | 1045114 |
| Feb 4, 2011 | Durham, NC | Devices | No Action Indicated (NAI) | 1045114 |
| Jul 1, 2010 | Durham, NC | Biologics | No Action Indicated (NAI) | 1045114 |
- 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 1045114 | Durham, NC | 5 | Sep 11, 2025 |
Duke University Health System IRB and the FDA: common questions
Has Duke University Health System IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Duke University Health System 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 Duke University Health System IRB received an FDA Form 483?
FDA has not published a Form 483 for "Duke University Health System IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Duke University Health System IRB?
The most recent FDA inspection on file ended Sep 11, 2025 at Durham, NC and was classified NAI. FDA has 5 inspections of Duke University Health System IRB on file.
Need more than this page shows? Ask about Duke University Health System IRB in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.