Company
Korea (the Republic of)Samsung Bioepis Co., Ltd., Yeonsu, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Samsung Bioepis Co., Ltd. in Yeonsu. 7 FDA inspections on record, 2 Form 483s, last inspected November 22, 2024.
Company Profile
This profile covers Samsung Bioepis Co., Ltd. based in Yeonsu, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected August 19, 2016. Last inspected November 22, 2024.
Most cited issue areas
- General responsibilities of sponsors1 inspection
- Reporting Requirements - submission of reports1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 22, 2024 | Not classified | Human Drugs | 1255085 |
| September 15, 2023 | VAI | Human Drugs · Bioresearch Monitoring | 1217751 |
| February 15, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1085327 |
| November 14, 2018 | Not classified | Human Drugs | 1084413 |
| March 7, 2018 | Not classified | Human Drugs | 1046814 |
| November 6, 2017 | Not classified | Human Drugs | 1042286 |
| August 19, 2016 | VAI | Human Drugs · Drug Quality Assurance | 988922 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Samsung Bioepis Co., Ltd.
FEI Number
3010031951
Address
76 Songdogyoyuk-Ro, Yeonsu, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 6473332d-84de-441c-82fe-4034d7383d5e