FDA Inspection
EMG Technology Co., Ltd.EMG Technology Co., Ltd. – FDA Inspection, Oct 23, 2014
Record Details
This FDA Inspection record concerns EMG Technology Co., Ltd., with an inspection on October 23, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EMG Technology Co., Ltd.
- Inspection Date
- October 23, 2014
- Product Type
- Devices
View Company Profile
ID · fca7b6f6-824b-4829-ba57-ade9ec4bcf0f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 902925
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.86Acceptance status
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EMG Technology Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2024 | Not classified | Office of Inspections and Investigations | |
| August 17, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 28, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 10, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for EMG Technology Co., Ltd.
- FDA Inspection 1261763 - 2024-12-13
- FDA Inspection 1024829 - 2017-08-17
- FDA Inspection 789180 - 2012-06-28
- FDA Inspection 616667 - 2009-09-10
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