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KLEB Inc

FDA Regulatory Profile

KLEB Inc has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "KLEB Inc" and its spelling variant "Kleb".

Latest inspection
Aug 24, 2023 · NAI

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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
Inspections12Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

KLEB Inc: FDA inspections per year 2017: 0 inspections020172018: 2 inspections220182019: 0 inspections020192020: 0 inspections020202021: 1 inspections120212022: 1 inspections120222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202210000
202110000
202000000
201900000
201820000
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.

Recent FDA inspections

12 inspections from Dec 2, 2009 to Aug 24, 2023.

DateSiteProductClassificationFEI
Aug 24, 2023Louisville, KYBiologicsNo Action Indicated (NAI)3013157033
Feb 23, 2022Lexington, KYBiologicsNo Action Indicated (NAI)3000718792
Jul 28, 2021Louisville, KYBiologicsNo Action Indicated (NAI)3013157033
Dec 19, 2018Lexington, KYBiologicsNo Action Indicated (NAI)3000718792
Feb 7, 2018Louisville, KYBiologicsNo Action Indicated (NAI)3013157033
Dec 8, 2016Lexington, KYBiologicsNo Action Indicated (NAI)3000718792
Feb 10, 2016Louisville, KYBiologicsNo Action Indicated (NAI)3013157033
Oct 30, 2014Lexington, KYBiologicsNo Action Indicated (NAI)3000718792
Jun 18, 2013Louisville, KYBiologicsNo Action Indicated (NAI)3013157033
Nov 9, 2012Lexington, KYBiologicsNo Action Indicated (NAI)3000718792
Sep 16, 2010Lexington, KYBiologicsNo Action Indicated (NAI)3000718792
Dec 2, 2009Louisville, KYBiologicsNo Action Indicated (NAI)3013157033
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

2 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3013157033Louisville, KY6Aug 24, 2023
FEI 3000718792Lexington, KY6Feb 23, 2022

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FDA data resources

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