Baptist Health Deaconess Madisonville Inc FDA Record
- Latest inspection VAI · Apr 24, 2025
- Last warning letter 2011
Baptist Health Deaconess Madisonville Inc has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Baptist Health Deaconess Madisonville Inc, the most recent on Apr 21, 2011. FDA has published 1 Form 483 for Baptist Health Deaconess Madisonville Inc.
- Latest inspection
- Apr 24, 2025 · VAI
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 | 9 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Baptist Health Deaconess Madisonville Inc: 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 | 1 | 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 | 1 | 0 | 0 | 0 | 0 |
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Baptist Health Deaconess Madisonville Inc FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Apr 21, 2011 · Record page |
Baptist Health Deaconess Madisonville Inc Form 483s
| Date | Document | FEI |
|---|---|---|
| Apr 24, 2025 · Document on fda.gov | 483 | 1070630 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 24, 2025 | Madisonville, KY | Biologics | Voluntary Action Indicated (VAI) | 1070630 |
| Jan 18, 2023 | Madisonville, KY | Biologics | No Action Indicated (NAI) | 1070630 |
| May 14, 2019 | Madisonville, KY | Biologics | No Action Indicated (NAI) | 1070630 |
| Mar 3, 2017 | Madisonville, KY | Biologics | No Action Indicated (NAI) | 1070630 |
| Feb 13, 2015 | Madisonville, KY | Biologics | No Action Indicated (NAI) | 1070630 |
| Jan 31, 2014 | Madisonville, KY | Biologics | Voluntary Action Indicated (VAI) | 1070630 |
| Oct 20, 2011 | Madisonville, KY | Biologics | Voluntary Action Indicated (VAI) | 1070630 |
| Feb 2, 2011 | Madisonville, KY | Biologics | Official Action Indicated (OAI) | 1070630 |
| Dec 18, 2008 | Madisonville, KY | Biologics | Voluntary Action Indicated (VAI) | 1070630 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Baptist Health Deaconess Madisonville Inc: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1070630 | Madisonville, KY | 9 | Apr 24, 2025 |
Baptist Health Deaconess Madisonville Inc and the FDA: common questions
Has Baptist Health Deaconess Madisonville Inc received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Baptist Health Deaconess Madisonville Inc. The most recent is dated Apr 21, 2011.
Has Baptist Health Deaconess Madisonville Inc received an FDA Form 483?
FDA has published 1 Form 483 for Baptist Health Deaconess Madisonville Inc in its reading room, the most recent dated Apr 24, 2025. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Baptist Health Deaconess Madisonville Inc?
The most recent FDA inspection on file ended Apr 24, 2025 at Madisonville, KY and was classified VAI. FDA has 9 inspections of Baptist Health Deaconess Madisonville Inc on file, 1 of them classified OAI (official action indicated).
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