Atlas

FDA-Inspected Site

Janssen Pharmaceuticals, Inc

17 FDA inspections are on record for Janssen Pharmaceuticals, Inc in Titusville, United States.

Clean· No action indicated

Titusville, United States · Last updated July 9, 2026

Overview

  • 17 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-14.

At a glance

Inspections

17

Form 483s

2

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 Aug 2025 – 14 Aug 2025Human DrugsClean
9 Sep 2024 – 27 Sep 2024Human Drugs483View 483 →
23 Sep 2020 – 28 Sep 2020Human DrugsClean
9 Sep 2020 – 14 Sep 2020Human DrugsClean
3 Oct 2017 – 6 Oct 2017Medical Devices & Rad HealthClean
14 Apr 2015 – 22 Apr 2015Human DrugsClean
3 Dec 2013 – 12 Dec 2013Human DrugsClean
16 Nov 2012Not recordedClean
28 Jun 2012Not recordedClean
1 Jun 2011Not recordedClean
9 Dec 2010Not recorded483View 483 →
9 Apr 2009Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

27 Sep 2024
FDCA 505-1(f)(4)

Failure to comply with REMS Implementation System

Cited by Jay B Shah

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

Investigators

FDA investigators tied to this site in the record.

Paul L Bellamy3 insp.
Michael Serrano2 insp.
Mindy M Chou1 insp.
John D Mcintosh1 insp.
Jay B Shah1 insp.
Nina Yang1 insp.
Guerlain Ulysse1 insp.
Loretta Nemchik1 insp.
Denise M Visco1 insp.
Dawn L Wydner1 insp.
Russell J Glapion1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

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
FDCA 505-1(f)(4)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Janssen Pharmaceuticals, Inc's 2 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat