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 3005841978.
Observations8
Issue DateApril 17, 2013
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Bio Focus Co. Ltd.
Location
Uiwang-si, -, Korea (the Republic of)
FEI Number
3005841978
Product Type
Devices
Issue Date
April 17, 2013
Country
Korea (the Republic of)
Inspection History, 2013 to 2015
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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