Form 483

Estee Lauder Cosmetics Ltd Form 483, 2017-09-29

FDA issued a Form 483 to Estee Lauder Cosmetics Ltd on 2017-09-29 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Estee Lauder Cosmetics Ltd · Scarborough, Canada · Issued September 29, 2017

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.

29 Sep 2017
21 CFR 211.101(b)

Measured components for manufacturing

Cited by Kara D Dobbin

29 Sep 2017
21 CFR 211.103

Yield calculations not verified by 2nd person

Cited by Kara D Dobbin

29 Sep 2017
21 CFR 211.188(b)(1)

Dates not included for each significant step

Cited by Kara D Dobbin

Inspected site

ELEstee Lauder Cosmetics LtdScarborough, Canada

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.101(b)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(1)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