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 3000247987.
Observations4
Issue DateJune 23, 2011
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Sewoon Medical Co., Ltd.
Location
Cheonan, -, Korea (the Republic of)
FEI Number
3000247987
Product Type
Devices
Issue Date
June 23, 2011
Country
Korea (the Republic of)
Inspection History, 2011 to 2025
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.