Company
Korea (the Republic of)Vatech Co., Ltd., Hwaseong, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for Vatech Co., Ltd. in Hwaseong. 2 FDA inspections on record, last inspected February 02, 2014.
Company Profile
This profile covers Vatech Co., Ltd. based in Hwaseong, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 10, 2011. Last inspected February 2, 2014.
Most cited issue areas
- Certification label or tag1 inspection
- Lack of or inadequate procedures for handling1 inspection
- Mandatory warning on control panel1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 2, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 864702 |
| June 10, 2011 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 734089 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Vatech Co., Ltd.
FEI Number
3004706313
Address
13 Samseong1ro2-Gil, Hwaseong, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 3590a2c1-5746-4100-977e-7683faf3ffdc