Baptist Health Deaconess Madisonville Inc FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection VAI · Apr 24, 2025
  • Last warning letter 2011
Inspections 9 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Apr 21, 2011
510(k) clearances 0 None on file

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.

What these totals cover: FDA records filed under the name "Baptist Health Deaconess Madisonville Inc" and its spelling variant "Baptist Health Deaconess Madisonville".

Latest inspection
Apr 24, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections9Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Baptist Health Deaconess Madisonville Inc's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Baptist Health Deaconess Madisonville Inc: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202310000
202200000
202100000
202000000
201910000
201800000
201710000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Baptist Health Deaconess Madisonville Inc FDA Warning Letters

1 warning letter on Apr 21, 2011.

IssuedSubjectIssuing officeClose-out letter
Apr 21, 2011 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Baptist Health Deaconess Madisonville Inc Form 483s

1 Form 483 published by FDA.

DateDocumentFEI
Apr 24, 2025 · Document on fda.gov 4831070630

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

9 inspections from Dec 18, 2008 to Apr 24, 2025.

DateSiteProductClassificationFEI
Apr 24, 2025Madisonville, KYBiologicsVoluntary Action Indicated (VAI)1070630
Jan 18, 2023Madisonville, KYBiologicsNo Action Indicated (NAI)1070630
May 14, 2019Madisonville, KYBiologicsNo Action Indicated (NAI)1070630
Mar 3, 2017Madisonville, KYBiologicsNo Action Indicated (NAI)1070630
Feb 13, 2015Madisonville, KYBiologicsNo Action Indicated (NAI)1070630
Jan 31, 2014Madisonville, KYBiologicsVoluntary Action Indicated (VAI)1070630
Oct 20, 2011Madisonville, KYBiologicsVoluntary Action Indicated (VAI)1070630
Feb 2, 2011Madisonville, KYBiologicsOfficial Action Indicated (OAI)1070630
Dec 18, 2008Madisonville, KYBiologicsVoluntary 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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

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.

Most recent: Warning Letter, Apr 21, 2011.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1070630Madisonville, KY9Apr 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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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.