Company
Korea (the Republic of)Seodong Medical Co, Busanjin District, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Seodong Medical Co in Busanjin District. 1 FDA inspection on record, 1 Form 483, last inspected May 03, 2018.
Company Profile
This profile covers Seodong Medical Co based in Busanjin District, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected May 3, 2018.
Most cited issue areas
- Design input - documentation1 inspection
- Design validation acceptance criteria1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 3, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1050565 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Seodong Medical Co
FEI Number
3007028871
Address
34 Geoje-Daero 36beonga-Gil, Busanjin District, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 3bc44364-bef9-4e54-9ec0-0b15b65c619c