Company
Korea (the Republic of)TIA, Gimje, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for TIA in Gimje. 5 FDA inspections on record, last inspected March 09, 2026.
Company Profile
This profile covers TIA based in Gimje, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected November 16, 2023. Last inspected March 9, 2026.
Most cited issue areas
- Label to bear a unique device identifier1 inspection
- Lack of Written MDR Procedures1 inspection
- Risk-based approach not applied to QMS processes1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 9, 2026 | NAI | Foods & Cosmetics · Foodborne Biological Hazards | 1306798 |
| February 11, 2026 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1302350 |
| July 15, 2025 | NAI | Foods & Cosmetics · Foodborne Biological Hazards | 1277479 |
| February 21, 2025 | VAI | Human Drugs · Bioresearch Monitoring | 1262952 |
| November 16, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1224865 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
TIA
FEI Number
3017405990
Address
20 Daedonggongdan2-Gil, Mangyeong-Eup, Gimje, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 13d724b0-631e-469c-8dd6-082b24280fad