Overview
- 12 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-14.
At a glance
Inspections
12
Form 483s
7
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Mar 2025 – 14 Mar 2025 | Human Drugs | Clean | |
| 16 Jan 2018 – 26 Jan 2018 | Human Drugs | 483 | View 483 → |
| 27 Jul 2015 – 6 Aug 2015 | Human Drugs | 483 | View 483 → |
| 30 Jul 2013 – 5 Aug 2013 | Human Drugs | 483 | View 483 → |
| 25 May 2012 | Not recorded | 483 | View 483 → |
| 25 May 2011 | Not recorded | 483 | On file |
| 23 Feb 2010 | Not recorded | 483 | View 483 → |
| 27 Apr 2009 | Not recorded | 483 | View 483 → |
| 7 May 2008 | Not recorded | Clean | |
| 18 Aug 2006 | Not recorded | Clean | |
| 14 Jun 2005 | Not recorded | Clean | |
| 18 Jun 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Jan 2018
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Jose O Hernandez, Christopher S Fields
26 Jan 2018
21 CFR 211.198(b)(2)
Complaint Investigation/Follow-Up Findings
Cited by Jose O Hernandez, Christopher S Fields
26 Jan 2018
21 CFR 211.42(c)
Defined areas of adequate size for operations
Cited by Jose O Hernandez, Christopher S Fields
26 Jan 2018
21 CFR 211.80(b)
Handling and Storage to Prevent Contamination
Cited by Jose O Hernandez, Christopher S Fields
26 Jan 2018
FDCA 760(b)(1)
Failure of responsible person to report AE (non-RX Drug)
Cited by Jose O Hernandez, Christopher S Fields
Investigators
FDA investigators tied to this site in the record.
Alice S Tsao3 insp.
Sony Mathews2 insp.
Adena S Yau1 insp.
Jose O Hernandez1 insp.
Christopher S Fields1 insp.
Mindy M Chou1 insp.
James A Liubicich1 insp.
Shreya Shah1 insp.
Thomas J Mooney1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.180(e)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 1x |
| FDCA 760(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind The Estee Lauder Inc's 7 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat