Company
Korea (the Republic of)Dentium Co., Ltd., Suwon, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Dentium Co., Ltd. in Suwon. 2 FDA inspections on record, last inspected April 17, 2014.
Company Profile
This profile covers Dentium Co., Ltd. based in Suwon, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected March 11, 2010. Last inspected April 17, 2014.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Not approved or obsolete document retrieval1 inspection
- Personnel1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 17, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 877464 |
| March 11, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 667527 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Dentium Co., Ltd.
FEI Number
3004578807
Address
76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 0d1a2c15-e5fa-429f-b3ae-0eefea64c985