Company
Korea (the Republic of)Celltrion Inc., Yeonsu, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Celltrion Inc. in Yeonsu. 9 FDA inspections on record (1 OAI), 3 Form 483s, 1 warning letter, last inspected January 14, 2025.
Company Profile
This profile covers Celltrion Inc. based in Yeonsu, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 9
- OAI
- 1
- VAI
- 5
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 1
First inspected April 9, 2015. Last inspected January 14, 2025.
Most cited issue areas
- Air Supply1 inspection
- General responsibilities of sponsors1 inspection
- Reporting Requirements - submission of reports1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 14, 2025 | Not classified | Human Drugs | 1280404 |
| May 3, 2024 | VAI | Human Drugs · Postmarket Surv. and Epidemiology | 1237995 |
| February 27, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1233221 |
| June 3, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1177098 |
| October 22, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1108245 |
| August 28, 2018 | Not classified | Human Drugs | 1071604 |
| July 17, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1061388 |
| June 2, 2017 | OAI | Human Drugs · Drug Quality Assurance | 1013498 |
| April 9, 2015 | NAI | Human Drugs · Bioresearch Monitoring | 926632 |
FDA documents
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Celltrion Inc.
FEI Number
3005241015
Address
19f Ibs Building, 263, Central-Ro, Yeonsu, Korea (the Republic of)
Country
Korea (the Republic of)
ID: d3991ec8-423b-4554-9d67-72bc27a8658b