Company
Korea (the Republic of)Shin Chang Medical Co., Ltd., Gumi, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Shin Chang Medical Co., Ltd. in Gumi. 3 FDA inspections on record, 2 Form 483s, last inspected December 05, 2024.
Company Profile
This profile covers Shin Chang Medical Co., Ltd. based in Gumi, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 26, 2018. Last inspected December 5, 2024.
Most cited issue areas
- Process control procedures, Lack of or inadequate procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design input - documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 5, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1256912 |
| November 17, 2022 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1191697 |
| April 26, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1050218 |
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
Shin Chang Medical Co., Ltd.
FEI Number
3003169040
Address
144 1gongdan-Ro 6-Gil, Gumi, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 9a21fb54-6950-4153-9e30-61a0851aa8ae