Company
Korea (the Republic of)SK Biotek Co., Ltd. (Sejong Plant), Sejong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for SK Biotek Co., Ltd. (Sejong Plant) in Sejong. 3 FDA inspections on record, 1 Form 483, last inspected June 10, 2026.
Company Profile
This profile covers SK Biotek Co., Ltd. (Sejong Plant) based in Sejong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 26, 2019. Last inspected June 10, 2026.
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 10, 2026 | Not classified | Human Drugs | 1325640 |
| March 22, 2024 | NAI | Human Drugs · Drug Quality Assurance | 1236751 |
| September 26, 2019 | Not classified | Human Drugs | 1109294 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
SK Biotek Co., Ltd. (Sejong Plant)
FEI Number
3014286622
Address
80 Myeonghaksandan-Ro, Yeondong-Myeon, Sejong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 22f4465e-20a8-43d1-9c64-52eacad2d9e4