Form 483

LVMH Fragrance Brands Form 483, 2019-09-13

FDA issued a Form 483 to LVMH Fragrance Brands on 2019-09-13 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

LVMH Fragrance Brands · Beauvais CEDEX, France · Issued September 13, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

13 Sep 2019
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Jamie L Dion

13 Sep 2019
21 CFR 211.188(b)(11)

Identification of Persons Performing Significant Steps

Cited by Jamie L Dion

13 Sep 2019
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Jamie L Dion

13 Sep 2019
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Jamie L Dion

Inspected site

LFLVMH Fragrance BrandsBeauvais CEDEX, France

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(11)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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