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 3005241015.
Observations1
Issue DateOctober 22, 2019
Status1 Related Warning Letter
Related Inspections7
Establishment Details
Firm
Celltrion Inc.
Location
Yeonsu District, -, Korea (the Republic of)
FEI Number
3005241015
Product Type
Drugs
Issue Date
October 22, 2019
Country
Korea (the Republic of)
Inspection History, 2015 to 2024
NAI1
VAI5
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.