Form 483

The Estee Lauder Inc Form 483, 2012-05-25

FDA issued a Form 483 to The Estee Lauder Inc on 2012-05-25 with 3 public-safe observations.

483· Form 483 issued3 observations

The Estee Lauder Inc · Melville, United States · Issued May 25, 2012

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

25 May 2012
21 CFR 211.28(a)

Protective Apparel Not Worn

Cited by Sony Mathews

25 May 2012
21 CFR 211.198(a)

Complaints reviewed by Quality Control Unit

Cited by Sony Mathews

25 May 2012
21 CFR 211.198(b)(2)

Complaint Investigation/Follow-Up Findings

Cited by Sony Mathews

Inspected site

TEThe Estee Lauder IncMelville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere