FDA Inspection
Vatech Co., Ltd.Vatech Co., Ltd. – FDA Inspection, Jun 10, 2011
Record Details
This FDA Inspection record concerns Vatech Co., Ltd., with an inspection on June 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vatech Co., Ltd.
- Inspection Date
- June 10, 2011
- Product Type
- Devices
View Company Profile
ID · adc9e592-7476-4802-bc3f-86039ebaabcc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734089
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
3- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 1020.30(j)Mandatory warning on control panel
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vatech Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vatech Co., Ltd.
- FDA Inspection 864702 - 2014-02-02
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