1219108

Celltrion Pharm, Inc. — FEI 3012279978

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 14, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Cheongju (Korea (the Republic of))

Citations

IDCFRDescription
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures