FDA Inspection
HanChuan FuMo Plastics Co., Ltd.HanChuan FuMo Plastics Co., Ltd. – FDA Inspection, Jan 14, 2015
Record Details
This FDA Inspection record concerns HanChuan FuMo Plastics Co., Ltd., with an inspection on January 14, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 14, 2015
- Product Type
- Devices
View Company Profile
ID · a3165dd6-65c3-4101-a2c0-39bb15ce06e0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 913035
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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