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 3010172486.
Observations2
Issue DateAugust 30, 2018
Status1 Related Warning Letter
Related Inspections2
Establishment Details
Firm
Philosys Co. Ltd
Location
Gunsan, -, Korea (the Republic of)
FEI Number
3010172486
Product Type
Devices
Issue Date
August 30, 2018
Country
Korea (the Republic of)
Inspection History, 2018 to 2023
VAI1
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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