FDA Inspection
GaleMed Xiamen Co., Ltd.GaleMed Xiamen Co., Ltd. – FDA Inspection, Dec 12, 2013
Record Details
This FDA Inspection record concerns GaleMed Xiamen Co., Ltd., with an inspection on December 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GaleMed Xiamen Co., Ltd.
- Inspection Date
- December 12, 2013
- Product Type
- Devices
View Company Profile
ID · 70a2608b-d721-49b4-a31e-e69ec4863782
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 860665
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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