Saint Luke's Hospital Of Kansas City FDA Record

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

  • Latest inspection NAI · Jun 25, 2025
  • No warning letters matched by name
Inspections 8 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Saint Luke's Hospital Of Kansas City has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Saint Luke's Hospital Of Kansas City" is on file.

What these totals cover: FDA records filed under the name "Saint Luke's Hospital Of Kansas City" and its spelling variant "Saint Luke Hospital Of Kansas City".

Latest inspection
Jun 25, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections8Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Saint Luke's Hospital Of Kansas City's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Saint Luke's Hospital Of Kansas City: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202210000
202100000
202000000
201900000
201810000
201700000

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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Recent FDA inspections

8 inspections from May 20, 2009 to Jun 25, 2025.

DateSiteProductClassificationFEI
Jun 25, 2025Kansas City, MOBiologicsNo Action Indicated (NAI)1970696
Feb 28, 2022Kansas City, MOBiologicsNo Action Indicated (NAI)1970696
Feb 28, 2018Kansas City, MOBiologicsNo Action Indicated (NAI)1970696
Mar 16, 2016Kansas City, MOBiologicsNo Action Indicated (NAI)1970696
Jun 25, 2014Kansas City, MOBiologicsNo Action Indicated (NAI)1970696
Mar 13, 2013Kansas City, MOBiologicsVoluntary Action Indicated (VAI)1970696
Mar 30, 2011Kansas City, MOBiologicsVoluntary Action Indicated (VAI)1970696
May 20, 2009Kansas City, MOBiologicsNo Action Indicated (NAI)1970696
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1970696Kansas City, MO8Jun 25, 2025

Saint Luke's Hospital Of Kansas City and the FDA: common questions

Has Saint Luke's Hospital Of Kansas City received an FDA warning letter?

No FDA warning letter addressed to the name "Saint Luke's Hospital Of Kansas City" 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 Saint Luke's Hospital Of Kansas City received an FDA Form 483?

FDA has not published a Form 483 for "Saint Luke's Hospital Of Kansas City" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Saint Luke's Hospital Of Kansas City?

The most recent FDA inspection on file ended Jun 25, 2025 at Kansas City, MO and was classified NAI. FDA has 8 inspections of Saint Luke's Hospital Of Kansas City on file.

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