Company
Korea (the Republic of)Sewoon Medical Co., Ltd., Cheonan, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Sewoon Medical Co., Ltd. in Cheonan. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected February 20, 2025.
Company Profile
This profile covers Sewoon Medical Co., Ltd. based in Cheonan, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected June 23, 2011. Last inspected February 20, 2025.
Most cited issue areas
- Design output - Lack of or inadequate procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 20, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1261809 |
| June 23, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 733070 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sewoon Medical Co., Ltd.
FEI Number
3000247987
Address
Ipjang-Myeon, Seobuk, 60 Dorim-Gil; Seobuk, Cheonan, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 31338ca3-eb58-4c38-8cfb-d4f7e916528c