Company
ChinaGaleMed Xiamen Co., Ltd., Xiamen, China – FDA Inspections
Inspection records and compliance data for GaleMed Xiamen Co., Ltd. in Xiamen. 1 FDA inspection on record (1 OAI), 1 warning letter, last inspected December 12, 2013.
Company Profile
This profile covers GaleMed Xiamen Co., Ltd. based in Xiamen, China.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
Inspected December 12, 2013.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 12, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 860665 |
FDA documents
Warning Letters (1)
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Company Information
Name
GaleMed Xiamen Co., Ltd.
FEI Number
3006783791
Address
Amoy Export, 39 East Rd; Haicang, Xiamen, China
Country
China
ID: c6fd85c4-f0fc-445d-8e0d-f5ab94d9ae14