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 3003044483.
Observations1
Issue DateMay 31, 2018
StatusNo Warning Letter
Related Inspections3
Establishment Details
Firm
HemoCue AB
Location
Angelholm, -, Sweden
FEI Number
3003044483
Product Type
Devices
Issue Date
May 31, 2018
Country
Sweden
Inspection History, 2011 to 2018
NAI1
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.