Company
Korea (the Republic of)Mediana Co., Ltd., Wonju, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Mediana Co., Ltd. in Wonju. 3 FDA inspections on record, 1 Form 483, last inspected September 06, 2018.
Company Profile
This profile covers Mediana Co., Ltd. based in Wonju, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected December 9, 2010. Last inspected September 6, 2018.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 6, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1069071 |
| July 24, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 891395 |
| December 9, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 705656 |
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
Mediana Co., Ltd.
FEI Number
3003591740
Address
132 Donghwagongdan-Ro, Munmag-Eup, Wonju, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 313475f1-f84a-4b2d-8fc6-29dff45ded87