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FDA establishment 3005241015, Yeonsu, Korea (the Republic of). Part of Celltrion's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 1
Last inspection ended: May 3, 2024
Warning letters: 2
Import refusals 2014 to 2023: 2, first Jul 30, 2021
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 600.80(c)(1)(iii). Reporting Requirements - submission of reports Failure to submit each post marketing 15-day alert and post marketing 15-day alert follow up report as required.
21 CFR 600.80(b). Review of Adverse Experiences - SOPs There are no written procedures for the surveillance, receipt and reporting of post-marketing adverse experiences to FDA.
21 CFR 312.50. General responsibilities of sponsors Failure to ensure proper monitoring of the study, ensure the study is conducted in accordance with the protocol and/or investigational plan and ensure that FDA and all investigators are promptly informed of significant new adverse effects or risks.
Voluntary Action Indicated (VAI)
Feb 27, 2024
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jun 3, 2022
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Oct 22, 2019
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.42(c)(10)(iii). Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
Voluntary Action Indicated (VAI)
Jul 17, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jun 2, 2017
Drugs · Drug Quality Assurance
None posted
Official Action Indicated (OAI)
Apr 9, 2015
Drugs · Bioresearch Monitoring
None posted
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Yeonsu, Korea (the Republic of). Part of