Atlas

Form 483

Janssen Pharmaceuticals, Inc Form 483, 2010-12-09

FDA issued a Form 483 to Janssen Pharmaceuticals, Inc on 2010-12-09 with 2 public-safe observations.

483· Form 483 issued2 observations

Janssen Pharmaceuticals, Inc · Titusville, United States · Issued December 9, 2010

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.

9 Dec 2010
21 CFR 58.105(a)

Test article: characterization

Cited by Denise M Visco, Dawn L Wydner

9 Dec 2010
21 CFR 511.1(b)(4)

No NCIE submitted

Cited by Denise M Visco, Dawn L Wydner

Inspected site

JPJanssen Pharmaceuticals, IncTitusville, United States

Inspection team

DMDenise M Visco
DLDawn L Wydner

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 511.1(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 58.105(a)Cited 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