Company
Korea (the Republic of)MEDIKAN CO., LTD., Gangseo, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for MEDIKAN CO., LTD. in Gangseo. 1 FDA inspection on record (1 OAI), last inspected August 14, 2014.
Company Profile
This profile covers MEDIKAN CO., LTD. based in Gangseo, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected August 14, 2014.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate procedures for labeling1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 14, 2014 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 893877 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
MEDIKAN CO., LTD.
FEI Number
3008624479
Address
217 Heojun-Ro, Gangseo, Rm 502 Gayang Ta, Gangseo, Korea (the Republic of)
Country
Korea (the Republic of)
ID: bae625b8-6ce2-4bfb-b03f-65b197fb0d0e