Company
Korea (the Republic of)Wonjin Mulsan Co., Ltd., Seo, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Wonjin Mulsan Co., Ltd. in Seo. 2 FDA inspections on record (2 OAI), 1 warning letter, last inspected October 22, 2015.
Company Profile
This profile covers Wonjin Mulsan Co., Ltd. based in Seo, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 2
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected April 4, 2013. Last inspected October 22, 2015.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 22, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 948403 |
| April 4, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 828626 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Wonjin Mulsan Co., Ltd.
FEI Number
3006797972
Address
Wonjinmulsan(Ju), 89 Geomdan-Ro, Seo, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 6b48e2e6-05e3-430b-9a7e-e4b3c7e1d79b