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Celltrion Branchburg, LLC

FDA Regulatory Profile

Celltrion Branchburg, LLC has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 25, 2022 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections10Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 25, 2022Branchburg, NJDrugsVoluntary Action Indicated (VAI)3002889358
Aug 21, 2020Branchburg, NJDrugsOfficial Action Indicated (OAI)3002889358
Nov 26, 2019Branchburg, NJDrugsOfficial Action Indicated (OAI)3002889358
Mar 9, 2018Branchburg, NJDrugsVoluntary Action Indicated (VAI)3002889358
Sep 21, 2017Branchburg, NJDrugsNo Action Indicated (NAI)3002889358
Jul 10, 2015Branchburg, NJDrugsNo Action Indicated (NAI)3002889358
Nov 13, 2013Branchburg, NJDrugsNo Action Indicated (NAI)3002889358
Dec 11, 2012Branchburg, NJDrugsNo Action Indicated (NAI)3002889358
Sep 28, 2011Branchburg, NJDrugsNo Action Indicated (NAI)3002889358
Oct 3, 2008Branchburg, NJDrugsNo Action Indicated (NAI)3002889358

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3002889358Branchburg, NJ10Aug 25, 2022

FDA data resources

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