Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3010031951.
Observations2
Issue DateNovember 22, 2024
StatusNo Warning Letter
Establishment TypeSponsor
Related Inspections4
Establishment Details
Firm
Samsung Bioepis Co., Ltd.
Location
Yeonsu, -, Republic of Korea
FEI Number
3010031951
Establishment Type
Sponsor
Product Type
Drugs
Issue Date
November 22, 2024
Country
Republic of Korea
Inspection History, 2016 to 2024
NAI1
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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