787444

Contec Medical Systems Co., Ltd. — FEI 3006979678

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 1, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Qinhuangdao (China)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
315921 CFR 820.184DHR content
320321 CFR 820.40(b)Document change records, maintained.
53721 CFR 820.70(a)Production processes
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures