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 3006179052.
Observations5
Issue DateSeptember 27, 2012
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Bistos Co Ltd
Location
Yongin, -, Korea (the Republic of)
FEI Number
3006179052
Product Type
Devices
Issue Date
September 27, 2012
Country
Korea (the Republic of)
Inspection History, 2012 to 2019
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.