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Estee Lauder Cosmetics Ltd — FDA Facility Profile

FEI 3000248560

Estee Lauder Cosmetics Ltd is an FDA-registered facility (FEI 3000248560) located in Scarborough, CA. Registered operations: MANUFACTURE. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Feb 24, 2023: Voluntary Action Indicated (VAI)
Inspections on record
4 (4 VAI)
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
Feb 24, 2023Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Absence of Written Procedures (21 CFR 211.100(a))
Investigations of discrepancies, failures (21 CFR 211.192)
Procedure Deviations Recorded and Justified (21 CFR 211.100(b))
and 2 more
Sep 29, 2017Voluntary Action Indicated (VAI)Yield calculations not verified by 2nd person (21 CFR 211.103)
Measured components for manufacturing (21 CFR 211.101(b))
Dates not included for each significant step (21 CFR 211.188(b)(1))
Sep 19, 2014Voluntary Action Indicated (VAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
GMP Training Frequency (21 CFR 211.25(a))
Written procedures not established/followed (21 CFR 211.67(b))
Computer control of master formula records (21 CFR 211.68(b))
and 10 more
Jan 26, 2012Voluntary Action Indicated (VAI)Calibration/Inspection/Checking not done (21 CFR 211.68(a))
SOPs not followed / documented (21 CFR 211.100(b))
Label reconciliation discrepancies evaluation/investigation (21 CFR 211.125(c))

Facility details

Company
Estee Lauder Cosmetics Ltd.
Location
Scarborough (CA)
Registration Expires
Dec 31, 2026
Operations
MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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