Northwestern Medicine Central DuPage Hospital FDA Record
- Latest inspection NAI · Aug 7, 2024
- No warning letters matched by name
Northwestern Medicine Central DuPage Hospital has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Northwestern Medicine Central DuPage Hospital" is on file.
- Latest inspection
- Aug 7, 2024 · 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 | 5 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Northwestern Medicine Central DuPage Hospital: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 7, 2024 | Winfield, IL | Biologics | No Action Indicated (NAI) | 1000159973 |
| Feb 4, 2020 | Winfield, IL | Biologics | No Action Indicated (NAI) | 1000159973 |
| Feb 22, 2019 | Winfield, IL | Biologics | Voluntary Action Indicated (VAI) | 1000159973 |
| Dec 22, 2015 | Winfield, IL | Biologics | No Action Indicated (NAI) | 1000159973 |
| Aug 24, 2009 | Winfield, IL | Biologics | No Action Indicated (NAI) | 1000159973 |
- 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 1000159973 | Winfield, IL | 5 | Aug 7, 2024 |
Northwestern Medicine Central DuPage Hospital and the FDA: common questions
Has Northwestern Medicine Central DuPage Hospital received an FDA warning letter?
No FDA warning letter addressed to the name "Northwestern Medicine Central DuPage Hospital" 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 Northwestern Medicine Central DuPage Hospital received an FDA Form 483?
FDA has not published a Form 483 for "Northwestern Medicine Central DuPage Hospital" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Northwestern Medicine Central DuPage Hospital?
The most recent FDA inspection on file ended Aug 7, 2024 at Winfield, IL and was classified NAI. FDA has 5 inspections of Northwestern Medicine Central DuPage Hospital on file.
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