Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3006979678.
Observations5
Issue DateJune 12, 2025
Status1 Related Warning Letter
Related Inspections4
Establishment Details
Firm
Contec Medical Systems Co., Ltd.
Location
Qinhuangdao, China
FEI Number
3006979678
Product Type
Devices
Issue Date
June 12, 2025
Country
China
Inspection History, 2012 to 2025
NAI1
VAI2
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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