Company
Korea (the Republic of)CG MedTech Co., Ltd., Uijeongbu, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for CG MedTech Co., Ltd. in Uijeongbu. 5 FDA inspections on record, 2 Form 483s, last inspected September 10, 2026.
Company Profile
This profile covers CG MedTech Co., Ltd. based in Uijeongbu, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected February 5, 2015. Last inspected September 10, 2026.
Most cited issue areas
- Complaint handling records not maintained1 inspection
- Contamination control, Lack of or inadequate procedures1 inspection
- Design control - no procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 10, 2026 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1327740 |
| June 15, 2023 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1209400 |
| November 14, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1112977 |
| March 30, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1023511 |
| February 5, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 922594 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
CG MedTech Co., Ltd.
FEI Number
3003200961
Address
20 Sandan-Ro 76 Beon-Gil, Uijeongbu, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 3b0b9840-df4f-48ee-af93-2fc9eb4cc05f