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Mary Kay, Inc

FDA Regulatory Profile

Mary Kay, Inc has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Mary Kay, Inc" and its spelling variant "Mary Kay".

Latest inspection
Oct 27, 2023 · VAI

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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
Inspections6Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Mary Kay, Inc: FDA inspections per year 2017: 2 inspections220172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202500000
202400000
202310000
202200000
202100000
202000000
201910000
201800000
201720000

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

6 inspections from Oct 2, 2009 to Oct 27, 2023.

DateSiteProductClassificationFEI
Oct 27, 2023Lewisville, TXDrugsVoluntary Action Indicated (VAI)3014970187
Jul 19, 2019Dallas, TXDrugsVoluntary Action Indicated (VAI)1618579
Sep 6, 2017Carrollton, TXFood/CosmeticsNo Action Indicated (NAI)3004352658
May 2, 2017Cypress, CAFood/CosmeticsNo Action Indicated (NAI)3002857974
Nov 17, 2015Dallas, TXDrugsVoluntary Action Indicated (VAI)1618579
Oct 2, 2009Dallas, TXDrugsNo Action Indicated (NAI)1618579
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

4 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3014970187Lewisville, TX1Oct 27, 2023
FEI 1618579Dallas, TX3Jul 19, 2019
FEI 3004352658Carrollton, TX1Sep 6, 2017
FEI 3002857974Cypress, CA1May 2, 2017

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FDA data resources

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