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1107697

Samchundang Pharm Co., Ltd. — FEI 3008425092

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 25, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hwaseong (Korea (the Republic of))

Facility

Other inspections at this facility

  • 1182341 (VAI Thu Oct 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1024442 (VAI Fri Sep 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
125621 CFR 211.68(b)Backup file not maintained
126321 CFR 211.68(b)Computer control of master formula records
141921 CFR 211.42(c)(8)Released Drug Products Area
142121 CFR 211.42(c)(10)Aseptic Processing Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
188521 CFR 211.165(b)Microbiological testing
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
203121 CFR 211.194(a)Complete test data included in records
241921 CFR 211.198(a)Complaint Handling Procedure
360321 CFR 211.160(b)Scientifically sound laboratory controls
434521 CFR 211.160(b)(1)Samples (various types) representative, identified properly
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action