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 3005128563.
Observations3
Issue DateDecember 02, 2010
StatusNo Warning Letter
Related Inspections3
Establishment Details
Firm
Alere (Shanghai) Diagnostics Co., Ltd.
Location
Shanghai, -, China
FEI Number
3005128563
Product Type
Devices
Issue Date
December 02, 2010
Country
China
Inspection History, 2010 to 2016
NAI2
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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