Company
Korea (the Republic of)Megagen Implant Co., Ltd., Gyeongsan, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Megagen Implant Co., Ltd. in Gyeongsan. 2 FDA inspections on record, last inspected May 23, 2013.
Company Profile
This profile covers Megagen Implant Co., Ltd. based in Gyeongsan, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected April 1, 2010. Last inspected May 23, 2013.
Most cited issue areas
- Lack of Written MDR Procedures1 inspection
- Process control procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 23, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 834605 |
| April 1, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 656994 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Megagen Implant Co., Ltd.
FEI Number
3005554774
Address
(Ju)Megajenimpeullanteu, 472 Hanjanggun-Ro; Jain-Myeon, Gyeongsan, Korea (the Republic of)
Country
Korea (the Republic of)
ID: f42b8b81-27e8-4104-a386-ab74172b9377