Atlas

FDA-Inspected Site

CELLTRION Inc

10 FDA inspections are on record for CELLTRION Inc in Yeonsu District, Korea (the Republic of).

Clean· No action indicated

Yeonsu District, Korea (the Republic of) · Last updated July 9, 2026

Overview

  • 10 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-01-14.

At a glance

Inspections

10

Form 483s

8

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Jan 2025 – 14 Jan 2025Human DrugsClean
22 Apr 2024 – 3 May 2024Human Drugs483View 483 →
19 Feb 2024 – 27 Feb 2024Human Drugs483On file
23 May 2022 – 3 Jun 2022Human Drugs483On file
14 Oct 2019 – 22 Oct 2019Human Drugs483View 483 →
20 Aug 2018 – 28 Aug 2018Human Drugs483On file
9 Jul 2018 – 17 Jul 2018Human Drugs483On file
22 May 2017 – 2 Jun 2017Human DrugsWLOn file
6 Apr 2015 – 9 Apr 2015Human DrugsClean
23 Feb 2015 – 6 Mar 2015Human Drugs483On file

Observations on record

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

3 May 2024
21 CFR 312.50

General responsibilities of sponsors

Cited by Scott N Lim

3 May 2024
21 CFR 600.80(b)

Review of Adverse Experiences - SOPs

Cited by Scott N Lim

3 May 2024
21 CFR 600.80(c)(1)(iii)

Reporting Requirements - submission of reports

Cited by Scott N Lim

22 Oct 2019
21 CFR 211.42(c)(10)(iii)

Air Supply

Cited by Matthew B Casale

Investigators

FDA investigators tied to this site in the record.

Ralph M Bernstein2 insp.
Hamet M Toure1 insp.
Karthik M Krishnan1 insp.
Prabuddha Sengupta1 insp.
Scott N Lim1 insp.
Saleem A Akhtar1 insp.
Zhong Li1 insp.
Hyung-Yul Lee1 insp.
Hao Kiet D Phan1 insp.
Wayne E Seifert1 insp.
Junho Pak1 insp.
Matthew B Casale1 insp.
Thuy T Nguyen1 insp.
Ashar P Parikh1 insp.
Richard Ledwidge1 insp.
Jacek Cieslak1 insp.
Justin A Boyd1 insp.
Stuart W Russell1 insp.
Reyes Candau-Chacon1 insp.
Bo Chi1 insp.
Chiang Syin1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.42(c)(10)(iii)Cited across public-safe Form 483 observations1x
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 600.80(b)Cited across public-safe Form 483 observations1x
21 CFR 600.80(c)(1)(iii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind CELLTRION Inc's 8 Form 483s

Source PDFs 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