Atlas

Form 483

Johnson & Johnson Consumer, Inc Form 483, 2013-08-30

FDA issued a Form 483 to Johnson & Johnson Consumer, Inc on 2013-08-30 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Johnson & Johnson Consumer, Inc · Lancaster, United States · Issued August 30, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

30 Aug 2013
21 CFR 211.63

Equipment Design, Size and Location

Cited by James M Mason, Karen E Dorazio

30 Aug 2013
21 CFR 211.192

Investigations of discrepancies, failures

Cited by James M Mason, Karen E Dorazio

Inspected site

J&Johnson & Johnson Consumer, IncLancaster, United States

Inspection team

JMJames M Mason
KEKaren E Dorazio

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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