CHI Health CUMC - Bergan Mercy FDA Record
- Latest inspection NAI · Mar 18, 2025
- No warning letters matched by name
CHI Health CUMC - Bergan Mercy has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "CHI Health CUMC - Bergan Mercy" is on file.
- Latest inspection
- Mar 18, 2025 · 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 | 6 | 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
CHI Health CUMC - Bergan Mercy: 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 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 18, 2025 | Omaha, NE | Biologics | No Action Indicated (NAI) | 3008819868 |
| Feb 17, 2022 | Omaha, NE | Biologics | No Action Indicated (NAI) | 3008819868 |
| Jul 11, 2018 | Omaha, NE | Biologics | No Action Indicated (NAI) | 3008819868 |
| Jun 1, 2016 | Omaha, NE | Biologics | No Action Indicated (NAI) | 3008819868 |
| Sep 4, 2014 | Omaha, NE | Biologics | No Action Indicated (NAI) | 3008819868 |
| Mar 20, 2012 | Omaha, NE | Biologics | No Action Indicated (NAI) | 3008819868 |
- 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 3008819868 | Omaha, NE | 6 | Mar 18, 2025 |
CHI Health CUMC - Bergan Mercy and the FDA: common questions
Has CHI Health CUMC - Bergan Mercy received an FDA warning letter?
No FDA warning letter addressed to the name "CHI Health CUMC - Bergan Mercy" 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 CHI Health CUMC - Bergan Mercy received an FDA Form 483?
FDA has not published a Form 483 for "CHI Health CUMC - Bergan Mercy" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect CHI Health CUMC - Bergan Mercy?
The most recent FDA inspection on file ended Mar 18, 2025 at Omaha, NE and was classified NAI. FDA has 6 inspections of CHI Health CUMC - Bergan Mercy on file.
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