Company
TaiwanGemore Technology Co., Ltd., Tan Shui, New Taipei City, Taiwan – FDA Inspections
Inspection records and compliance data for Gemore Technology Co., Ltd. in Tan Shui, New Taipei City. 2 FDA inspections on record, last inspected July 21, 2016.
Company Profile
This profile covers Gemore Technology Co., Ltd. based in Tan Shui, New Taipei City, Taiwan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected March 20, 2014. Last inspected July 21, 2016.
Most cited issue areas
- Design history file1 inspection
- Design input - Lack of or inadequate procedures1 inspection
- Design review - Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 21, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 984865 |
| March 20, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 873183 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gemore Technology Co., Ltd.
FEI Number
3004146401
Address
No. 29-5, Sec. 2, 11 Fl; Chung Cheng E. Rd., Tan Shui, New Taipei City, Taiwan
Country
Taiwan
ID: 48c4d5c8-1950-4b9d-a0be-6e021a9d8331