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CELLTRION Inc FDA Inspection Record

FEI 3005241015 · Inspections, Form 483s, warning letters and import refusals

CELLTRION Inc is an FDA-registered facility (FEI 3005241015) located in South (KOR). Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
May 3, 2024: Voluntary Action Indicated (VAI)
Inspections on record
7 (1 OAI, 5 VAI, 1 NAI)
Last OAI inspection
Jun 2, 2017
Warning letters
1 listed by FDA for this FEI, latest Jan 29, 2018
Form 483 and inspection documents
2 in FDA's reading room
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 3, 2024Voluntary Action Indicated (VAI)General responsibilities of sponsors (21 CFR 312.50)
Review of Adverse Experiences - SOPs (21 CFR 600.80(b))
Reporting Requirements - submission of reports (21 CFR 600.80(c)(1)(iii))
Feb 27, 2024Voluntary Action Indicated (VAI)No citations listed
Jun 3, 2022Voluntary Action Indicated (VAI)No citations listed
Oct 22, 2019Voluntary Action Indicated (VAI)Air Supply (21 CFR 211.42(c)(10)(iii))
Jul 17, 2018Voluntary Action Indicated (VAI)No citations listed
Jun 2, 2017Official Action Indicated (OAI)No citations listed
Apr 9, 2015No Action Indicated (NAI)No citations listed

Form 483s and inspection documents

FDA record score

26 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

7 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsJan 29, 201830 x 0.257.5
Inspection classified OAIJun 2, 201730 x 0.257.5
Inspection classified VAIMay 3, 20246 x 0.63.6
Inspection classified VAIFeb 27, 20246 x 0.63.6
Inspection classified VAIJun 3, 20226 x 0.63.6
Inspection classified VAIOct 22, 2019Only the 3 most recent VAI inspections add points0
Inspection classified VAIJul 17, 2018Only the 3 most recent VAI inspections add points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Celltrion Inc.
Location
South (KOR)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
Source
decrs

Compliance actions

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.