Atlas

Form 483

Janssen Pharmaceutica, N.V. Form 483, 2014-05-14

FDA issued a Form 483 to Janssen Pharmaceutica, N.V. on 2014-05-14 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Janssen Pharmaceutica, N.V. · Beerse, Belgium · Issued May 14, 2014

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.

14 May 2014
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Nadeem I Chaudhry, Rafael E Arroyo

14 May 2014
21 CFR 211.192

Quality control unit review of records

Cited by Nadeem I Chaudhry, Rafael E Arroyo

Inspected site

JPJanssen Pharmaceutica, N.V.Beerse, Belgium

Inspection team

NINadeem I Chaudhry
RERafael E Arroyo

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited 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