Atlas

FDA-Inspected Site

Celltrion Branchburg, LLC

16 FDA inspections are on record for Celltrion Branchburg, LLC in Branchburg, United States.

483· Form 483 issued

Branchburg, United States · Last updated July 9, 2026

Overview

  • 16 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-07-27.

At a glance

Inspections

16

Form 483s

6

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Jul 2023 – 27 Jul 2023Human Drugs483On file
26 Jul 2022 – 25 Aug 2022Human Drugs483On file
27 Jul 2020 – 21 Aug 2020Human Drugs483On file
12 Nov 2019 – 26 Nov 2019Human Drugs483On file
5 Mar 2018 – 9 Mar 2018Human Drugs483On file
12 Sep 2017 – 21 Sep 2017Human DrugsClean
21 Mar 2016 – 24 Mar 2016Human DrugsClean
7 Jul 2015 – 10 Jul 2015Human DrugsClean
2 Mar 2015 – 6 Mar 2015Human DrugsClean
4 Nov 2013 – 13 Nov 2013Human DrugsClean
11 Dec 2012Not recordedClean
28 Sep 2011Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Paul L Bellamy3 insp.
Tamil Arasu2 insp.
Wayne E Seifert1 insp.
Edmund F Mrak1 insp.
Kathleen M Jordan1 insp.
Ko U Min1 insp.
Guerlain Ulysse1 insp.
Yvesna C Blaise1 insp.
Jose O Hernandez1 insp.
Russell J Glapion1 insp.
Patricia F Hughes Troost1 insp.
Saleem A Akhtar1 insp.
Michael R Klapal1 insp.
Zhihao Pete Qiu1 insp.
Alberto A Viciedo1 insp.
Dawn L Wydner1 insp.

Full site report

Get the verbatim findings behind Celltrion Branchburg, LLC'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