Form 483

L'Oreal USA Products Inc Form 483, 2018-11-29

FDA issued a Form 483 to L'Oreal USA Products Inc on 2018-11-29 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

L'Oreal USA Products Inc · Piscataway, United States · Issued November 29, 2018

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.

29 Nov 2018
21 CFR 211.165(b)

Microbiological testing

Cited by Nancy F Scheraga

29 Nov 2018
21 CFR 211.170(b)

Annual visual exams of drug products

Cited by Nancy F Scheraga

29 Nov 2018
21 CFR 211.194(a)(1)

Description and Identification of Samples

Cited by Nancy F Scheraga

29 Nov 2018
21 CFR 211.25(a)

GMP Training Frequency

Cited by Nancy F Scheraga

Inspected site

LUL'Oreal USA Products IncPiscataway, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)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