Atlas

FDA-Inspected Site

Janssen Biotech, Inc.

16 FDA inspections are on record for Janssen Biotech, Inc. in Malvern, United States.

483· Form 483 issued

Malvern, United States · Last updated July 10, 2026

Overview

  • 16 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-07-29.

At a glance

Inspections

16

Form 483s

6

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Jul 2025 – 29 Jul 2025Human Drugs483On file
5 Mar 2025 – 10 Mar 2025BiologicsClean
26 Nov 2018 – 30 Nov 2018Human DrugsClean
21 Feb 2018 – 5 Mar 2018Human Drugs483On file
15 Sep 2014 – 24 Sep 2014Human Drugs483On file
25 Sep 2012Not recordedClean
15 Jun 2012Not recorded483On file
20 May 2011Not recorded483On file
18 Aug 2009Not recorded483On file
13 Nov 2008Not recordedClean
18 Apr 2008Not recordedClean
30 Nov 2006Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Anita R Michael3 insp.
Joseph L Despins2 insp.
Junho Pak1 insp.
Syeda N Mahazabin1 insp.
Ruben C Quintana1 insp.
Alan L Truong1 insp.
Anastasia I Offordile1 insp.
Yangmin Ning1 insp.
Gayle S Lawson1 insp.
Thomas E Friel1 insp.
James M Mason1 insp.
Julianne C Mccullough1 insp.
Vlada Matusovsky1 insp.
George Pyramides1 insp.
Stephanie C Mangigian1 insp.
Cynthia White1 insp.

Full site report

Get the verbatim findings behind Janssen Biotech, Inc.'s 6 Form 483s

The full inspection record, as Atlas holds it, 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