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 warning letter, 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
- 0
- Warning letters
- 1
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: Devices | 1260163 |
FDA documents
Warning Letters (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
DFI Co., Ltd.
Address
388-25 Gomo-Ro, Jillye-Myeon, Gimhae, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 75f4fdd2-dd69-4b31-8c05-806e3520a096