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 3008727514.
Observations6
Issue DateSeptember 19, 2014
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Criticare Systems (Malaysia) Sdn. Bhd.
Location
Nusajaya, -, Malaysia
FEI Number
3008727514
Product Type
Devices
Issue Date
September 19, 2014
Country
Malaysia
Inspection History, 2014 to 2015
NAI1
OAI1
NAI means No Action Indicated. OAI means Official Action Indicated.
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