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The Estee Lauder Inc. FDA Inspection Record

FEI 2418643 · Inspections, Form 483s, warning letters and import refusals

The Estee Lauder Inc. is an FDA-inspected facility (FEI 2418643) located in Melville, NY, US. RegDataLab tracks 8 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 14, 2025: No Action Indicated (NAI)
Inspections on record
8 (7 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
10 or more

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
Mar 14, 2025No Action Indicated (NAI)No citations listed
Jan 26, 2018Voluntary Action Indicated (VAI)Defined areas of adequate size for operations (21 CFR 211.42(c))
SOPs not followed / documented (21 CFR 211.100(b))
Handling and Storage to Prevent Contamination (21 CFR 211.80(b))
Complaint Investigation/Follow-Up Findings (21 CFR 211.198(b)(2))
and 1 more
Aug 6, 2015Voluntary Action Indicated (VAI)Approve or reject components, products (21 CFR 211.22(a))
Procedures not in writing, fully followed (21 CFR 211.22(d))
GMP Training Frequency (21 CFR 211.25(a))
Habits of good sanitation & health (21 CFR 211.28(b))
and 10 more
Aug 5, 2013Voluntary Action Indicated (VAI)Habits of good sanitation & health (21 CFR 211.28(b))
Testing and release for distribution (21 CFR 211.165(a))
Procedure Deviations Recorded and Justified (21 CFR 211.100(b))
May 25, 2012Voluntary Action Indicated (VAI)Protective Apparel Not Worn (21 CFR 211.28(a))
Complaint Investigation/Follow-Up Findings (21 CFR 211.198(b)(2))
Complaints reviewed by Quality Control Unit (21 CFR 211.198(a))
May 25, 2011Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Testing and release for distribution (21 CFR 211.165(a))
Adequate number of batches on stability (21 CFR 211.166(b))
Control procedures to monitor and validate performance (21 CFR 211.110(a))
and 2 more
Feb 23, 2010Voluntary Action Indicated (VAI)Reprocessing procedures lack steps to be taken (21 CFR 211.115(a))
Apr 27, 2009Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
Items to cover on annual reviews (21 CFR 211.180(e)(2))

FDA record score

3 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

12 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIJan 26, 20186 x 0.251.5
16 import refusals in 2017Dec 31, 20172 x 0.250.5
19 import refusals in 2016Dec 31, 20162 x 0.250.5
Inspection classified VAIAug 6, 201510 years or older, so it adds no points0
20 import refusals in 2014Dec 31, 201410 years or older, so it adds no points0
24 import refusals in 2013Dec 31, 201310 years or older, so it adds no points0
Inspection classified VAIAug 5, 201310 years or older, so it adds no points0
Inspection classified VAIMay 25, 201210 years or older, so it adds no points0
Inspection classified VAIMay 25, 201110 years or older, so it adds no points0
10 import refusals in 2010Dec 31, 201010 years or older, so it adds no points0
Inspection classified VAIFeb 23, 201010 years or older, so it adds no points0
Inspection classified VAIApr 27, 200910 years or older, so it adds no points0

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
The Estee Lauder Inc.
Location
Melville, NY (US)
Source
inspections

Import refusals

FDA data resources

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