Denver Health Medical Center FDA Record
- Latest inspection VAI · Jun 5, 2025
- No warning letters matched by name
Denver Health Medical Center has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Denver Health Medical Center" is on file. FDA has published 1 Form 483 for Denver Health Medical Center.
- Latest inspection
- Jun 5, 2025 · VAI
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 | 7 | 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
Denver Health Medical Center: 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 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Denver Health Medical Center Form 483s
| Date | Document | FEI |
|---|---|---|
| Jun 5, 2025 · Document on fda.gov | 483 | 1000065349 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 5, 2025 | Denver, CO | Biologics | Voluntary Action Indicated (VAI) | 1000065349 |
| Mar 6, 2020 | Denver, CO | Biologics | No Action Indicated (NAI) | 1000065349 |
| Oct 26, 2017 | Denver, CO | Biologics | No Action Indicated (NAI) | 1000065349 |
| Nov 23, 2015 | Denver, CO | Biologics | No Action Indicated (NAI) | 1000065349 |
| Dec 12, 2013 | Denver, CO | Biologics | Voluntary Action Indicated (VAI) | 1000065349 |
| May 23, 2012 | Denver, CO | Biologics | No Action Indicated (NAI) | 1000065349 |
| Jun 30, 2010 | Denver, CO | Biologics | Voluntary Action Indicated (VAI) | 1000065349 |
- 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 1000065349 | Denver, CO | 7 | Jun 5, 2025 |
Denver Health Medical Center and the FDA: common questions
Has Denver Health Medical Center received an FDA warning letter?
No FDA warning letter addressed to the name "Denver Health Medical Center" 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 Denver Health Medical Center received an FDA Form 483?
FDA has published 1 Form 483 for Denver Health Medical Center in its reading room, the most recent dated Jun 5, 2025. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Denver Health Medical Center?
The most recent FDA inspection on file ended Jun 5, 2025 at Denver, CO and was classified VAI. FDA has 7 inspections of Denver Health Medical Center on file.
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