Company
Korea (the Republic of)DFI Co., Ltd., Gimhae, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for DFI Co., Ltd. in Gimhae, -. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected January 09, 2025.
Company Profile
This profile covers DFI Co., Ltd. based in Gimhae, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected January 9, 2025.
Most cited issue areas
- Design control - no procedures1 inspection
- DHR content1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 9, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1260163 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
DFI Co., Ltd.
FEI Number
3005841640
Address
Gimhae, - -, Korea (the Republic of)
Country
Korea (the Republic of)
ID: d5226023-1f19-4336-ae11-b1ae820b096e