Company
Korea (the Republic of)INSUNG MEDICAL CO LTD, Wonju, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for INSUNG MEDICAL CO LTD in Wonju. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected May 01, 2025.
Company Profile
This profile covers INSUNG MEDICAL CO LTD based in Wonju, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected May 1, 2025.
Most cited issue areas
- Design input - documentation1 inspection
- Design validation - user needs and intended uses1 inspection
- Devices subject to device identification GUDID data submission requirements.1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 1, 2025 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1272999 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
INSUNG MEDICAL CO LTD
FEI Number
3013023209
Address
168 Gieopdosi-Ro, Jijeong-Myeon, Wonju, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 79344663-05c3-4a6a-b9ee-e90dd8d04126