# Celltrion Inc., Yeonsu, Korea (the Republic of) – FDA Inspections

Source: https://www.keypedia.com/companies/celltrion-inc/d3991ec8-423b-4554-9d67-72bc27a8658b

> 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.

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## Details

- Name: Celltrion Inc.
- FEI Number: 3005241015
- Facility Type: Sterile Injectable Drug Product and Drug Substance Manufacturer
- Address Line 1: 19f Ibs Building, 263, Central-Ro
- City: Yeonsu
- Country Name: Korea (the Republic of)
- Address: 19f Ibs Building, 263, Central-Ro, Yeonsu, Korea (the Republic of)
- Country: Korea (the Republic of)

## Related Documents

- [CRL - Celltrion Inc. - Unknown Date](https://www.keypedia.com/records/crl/celltrion-inc/00dd6879-daed-432a-890e-e99047d24852) — source: FDA, date: Invalid Date
- [CRL - Celltrion Inc. - Unknown Date](https://www.keypedia.com/records/crl/celltrion-inc/0763a33e-2365-43bd-9c70-1bdec22e4f9c) — source: FDA, date: Invalid Date
- [CRL - Celltrion Inc. - Unknown Date](https://www.keypedia.com/records/crl/celltrion-inc/852dfc18-c5b9-4e7b-a308-3f9183dd0a6c) — source: FDA, date: Invalid Date
- [CRL - Celltrion Inc. - Unknown Date](https://www.keypedia.com/records/crl/celltrion-inc/74e9d282-eb72-4964-ae8d-7258a3bac126) — source: FDA, date: Invalid Date
- [CRL - Celltrion Inc. - Unknown Date](https://www.keypedia.com/records/crl/celltrion-inc/3e68c5ca-8c63-410a-8bf5-7591534a6c83) — source: FDA, date: Invalid Date
- [FDA Inspection 1280404 - Celltrion Inc. - 2025-01-14](https://www.keypedia.com/records/fda_inspections/celltrion-inc/5800cd52-ff00-4bd9-80ef-338d3d5b7159) — source: FDA, date: January 14, 2025
- [FDA Inspection 1237995 - Celltrion Inc. - 2024-05-03](https://www.keypedia.com/records/fda_inspections/celltrion-inc/e427a948-24ab-4779-9b7a-cbcf8db5d4b9) — classification: Voluntary Action Indicated (VAI), source: FDA, date: May 3, 2024
- FDA Inspection 1237995 - Celltrion Inc. - 2024-05-03 — classification: Voluntary Action Indicated (VAI), source: FDA, date: May 3, 2024
- [483 - Celltrion Inc. - 2024-02-27](https://www.keypedia.com/records/483/celltrion-inc/069dc9c9-4802-427e-9698-6f3658d5e157) — source: FDA, date: February 27, 2024
- FDA Inspection 1233221 - Celltrion Inc. - 2024-02-27 — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 27, 2024
- [483 - Celltrion Inc. - 2022-06-03](https://www.keypedia.com/records/483/celltrion-inc/45210b1b-c256-4675-b160-8f544705ebe1) — source: FDA, date: June 3, 2022
- FDA Inspection 1177098 - Celltrion Inc. - 2022-06-03 — classification: Voluntary Action Indicated (VAI), source: FDA, date: June 3, 2022
- [483 - Celltrion Inc. - 2019-10-22](https://www.keypedia.com/records/483/celltrion-inc/57f6ed48-3c6c-4460-80ee-647bd64b5189) — source: FDA, date: October 22, 2019
- [FDA Inspection 1108245 - Celltrion Inc. - 2019-10-22](https://www.keypedia.com/records/fda_inspections/celltrion-inc/31d22129-bbff-4836-8162-a11953f41efe) — classification: Voluntary Action Indicated (VAI), source: FDA, date: October 22, 2019
- [FDA Inspection 1071604 - Celltrion Inc. - 2018-08-28](https://www.keypedia.com/records/fda_inspections/celltrion-inc/3d941692-3f0e-4112-87b6-0c5c353634ef) — source: FDA, date: August 28, 2018
- [483 - Celltrion Inc. - 2018-07-17](https://www.keypedia.com/records/483/celltrion-inc/7ab1960a-3b2f-40fd-b849-e01aeb533916) — source: FDA, date: July 17, 2018
- [FDA Inspection 1061388 - Celltrion Inc. - 2018-07-17](https://www.keypedia.com/records/fda_inspections/celltrion-inc/b47b4db9-5ff7-4eb4-a2d5-2e7de29adbe1) — classification: Voluntary Action Indicated (VAI), source: FDA, date: July 17, 2018
- [WARNING_LETTER - Celltrion Inc. - 2017-06-02](https://www.keypedia.com/records/warning_letter/celltrion-inc/97c71402-61db-4b70-addc-79cb8b87a3c0) — source: FDA, date: June 2, 2017
- [FDA Inspection 1013498 - Celltrion Inc. - 2017-06-02](https://www.keypedia.com/records/fda_inspections/celltrion-inc/30983a3a-f527-4b2f-b901-47287f8403d4) — classification: Official Action Indicated (OAI), source: FDA, date: June 2, 2017
- FDA Inspection 926632 - Celltrion Inc. - 2015-04-09 — classification: No Action Indicated (NAI), source: FDA, date: April 9, 2015

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