Company
Korea (the Republic of)Samsung Biologics Co., Ltd., Yeonsu-gu, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Samsung Biologics Co., Ltd. in Yeonsu-gu. 10 FDA inspections on record, 9 Form 483s, last inspected May 27, 2025.
Company Profile
This profile covers Samsung Biologics Co., Ltd. based in Yeonsu-gu, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Unclassified
- 6
- Form 483s
- 9
- Warning letters
- 0
First inspected July 25, 2017. Last inspected May 27, 2025.
Most cited issue areas
- Equipment Design, Size and Location1 inspection
- Procedure Deviations Recorded and Justified1 inspection
- Training , Education , Experience overall1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 27, 2025 | Not classified | Biologics | 1269570 |
| July 30, 2024 | Not classified | Human Drugs | 1261652 |
| September 1, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1218067 |
| February 28, 2023 | VAI | Biologics · Blood and Blood Products | 1201856 |
| November 1, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1108244 |
| September 10, 2019 | Not classified | Human Drugs | 1105813 |
| June 26, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1056899 |
| May 11, 2018 | Not classified | Human Drugs | 1052792 |
| March 14, 2018 | Not classified | Human Drugs | 1046813 |
| July 25, 2017 | Not classified | Human Drugs | 1025178 |
FDA documents
Form 483s (14)
- Form 483s · May 27, 2025
- Form 483s · July 30, 2024
- Form 483s · September 1, 2023
- Form 483s · February 20, 2023
- Form 483s · June 9, 2022
- Form 483s · August 24, 2021
- Form 483s · November 1, 2019
- Form 483s · September 10, 2019
- Form 483s · June 26, 2018
- Form 483s · March 14, 2018
- Form 483s · July 25, 2017
- Form 483s
- Form 483s
- Form 483s
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Samsung Biologics Co., Ltd.
FEI Number
3010479596
Address
300 Songdo Bio-Daero, Yeonsu-gu, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 817b7bc4-2de1-47f4-b552-178303c8da01