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Baptist Health Deaconess Madisonville Inc FDA Inspection Record

FEI 1070630 · Inspections, Form 483s, warning letters and import refusals

Baptist Health Deaconess Madisonville Inc is an FDA-inspected facility (FEI 1070630) located in Madisonville, KY, US. RegDataLab tracks 9 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 24, 2025: Voluntary Action Indicated (VAI)
Inspections on record
9 (1 OAI, 4 VAI, 4 NAI)
Last OAI inspection
Feb 2, 2011
Warning letters
1 listed by FDA for this FEI, latest Apr 21, 2011
Form 483 and inspection documents
1 in FDA's reading room

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 24, 2025Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Thorough investigations (21 CFR 606.100(c))
Jan 18, 2023No Action Indicated (NAI)No citations listed
May 14, 2019No Action Indicated (NAI)No citations listed
Mar 3, 2017No Action Indicated (NAI)No citations listed
Feb 13, 2015No Action Indicated (NAI)No citations listed
Jan 31, 2014Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Adverse Reaction - Investigations (21 CFR 606.170(a))
Lookback System [Collecting Establishment] (21 CFR 610.47(a))
Lookback System [Collecting Establishment] (21 CFR 610.46(a))
and 5 more
Oct 20, 2011Voluntary Action Indicated (VAI)No citations listed
Feb 2, 2011Official Action Indicated (OAI)SOPs not followed / documented (21 CFR 211.100(b))
Donor suitability procedures not followed (21 CFR 640.3(a)(1))
Arm preparation (21 CFR 640.4(f))
Donor eligibility (21 CFR 640.31)
and 5 more
Dec 18, 2008Voluntary Action Indicated (VAI)Required records (21 CFR 606.160(b))
Legibility and indelibility (21 CFR 606.160(a)(1))
Quality control (21 CFR 640.25(b))
Corrective action (21 CFR 640.25(b)(4))
and 4 more

Form 483s and inspection documents

  • 483 on FDA.gov
    Inspection on Apr 24, 2025, issued Apr 24, 2025 (dates printed on the document). FDA listing date Apr 24, 2025. Published by FDA Oct 30, 2026.

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Baptist Health Deaconess Madisonville Inc
Location
Madisonville, KY (US)
Source
inspections

Compliance actions

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.