Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-24.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Feb 2023 – 24 Feb 2023 | Human Drugs | 483 | View 483 → |
| 25 Sep 2017 – 29 Sep 2017 | Human Drugs | 483 | View 483 → |
| 15 Sep 2014 – 19 Sep 2014 | Human Drugs | 483 | View 483 → |
| 26 Jan 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Feb 2023
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Sena G Dissmeyer, Brandy N Lepage
24 Feb 2023
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Sena G Dissmeyer, Brandy N Lepage
24 Feb 2023
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Sena G Dissmeyer, Brandy N Lepage
24 Feb 2023
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Sena G Dissmeyer, Brandy N Lepage
Investigators
FDA investigators tied to this site in the record.
Sena G Dissmeyer1 insp.
Brandy N Lepage1 insp.
Kara D Dobbin1 insp.
Justin A Boyd1 insp.
Charisse K Green1 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 | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(1) | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Estee Lauder Cosmetics Ltd's 4 Form 483s
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