Western Kentucky Regional Blood Ctr FDA Record
Western Kentucky Regional Blood Ctr has 0 FDA recalls, 14 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Western Kentucky Regional Blood Ctr" is on file.
- Latest inspection
- Mar 24, 2026 · 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 | 14 | 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
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 24, 2026 | Hopkinsville, KY | Biologics | No Action Indicated (NAI) | 1047731 |
| Apr 23, 2025 | Owensboro, KY | Biologics | Voluntary Action Indicated (VAI) | 1045410 |
| Aug 18, 2023 | Owensboro, KY | Biologics | No Action Indicated (NAI) | 1045410 |
| Aug 30, 2021 | Hopkinsville, KY | Biologics | No Action Indicated (NAI) | 1047731 |
| Jun 29, 2018 | Owensboro, KY | Biologics | No Action Indicated (NAI) | 1045410 |
| Jun 6, 2018 | Hopkinsville, KY | Biologics | No Action Indicated (NAI) | 1047731 |
| Mar 24, 2016 | Owensboro, KY | Biologics | No Action Indicated (NAI) | 1045410 |
| Mar 9, 2016 | Hopkinsville, KY | Biologics | No Action Indicated (NAI) | 1047731 |
| Feb 28, 2014 | Owensboro, KY | Biologics | Voluntary Action Indicated (VAI) | 1045410 |
| Jan 14, 2014 | Hopkinsville, KY | Biologics | Voluntary Action Indicated (VAI) | 1047731 |
| Mar 9, 2012 | Owensboro, KY | Biologics | Voluntary Action Indicated (VAI) | 1045410 |
| Oct 27, 2011 | Hopkinsville, KY | Biologics | No Action Indicated (NAI) | 1047731 |
| Jul 22, 2010 | Hopkinsville, KY | Biologics | Voluntary Action Indicated (VAI) | 1047731 |
| Feb 23, 2010 | Owensboro, KY | Biologics | No Action Indicated (NAI) | 1045410 |
- 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 1047731 | Hopkinsville, KY | 7 | Mar 24, 2026 |
| FEI 1045410 | Owensboro, KY | 7 | Apr 23, 2025 |
Western Kentucky Regional Blood Ctr and the FDA: common questions
Has Western Kentucky Regional Blood Ctr received an FDA warning letter?
No FDA warning letter addressed to the name "Western Kentucky Regional Blood Ctr" 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 Western Kentucky Regional Blood Ctr received an FDA Form 483?
FDA has not published a Form 483 for "Western Kentucky Regional Blood Ctr" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Western Kentucky Regional Blood Ctr?
The most recent FDA inspection on file ended Mar 24, 2026 at Hopkinsville, KY and was classified NAI. FDA has 14 inspections of Western Kentucky Regional Blood Ctr on file.
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