1017841

Nots Co., Ltd — FEI 3012258527

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 23, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gangnam (Korea (the Republic of))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
154021 CFR 211.125(a)Strict control not exercised over labeling issued
154121 CFR 211.125(b)Examination of issued labels
162621 CFR 211.130Procedures are written, and followed
177721 CFR 211.150(b)Distribution Recall System
434221 CFR 211.142(b)Storage under appropriate conditions
438921 CFR 211.198(a)Procedures to be written and followed