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1261013

Sinsin Pharmaceutical Co., Ltd. — FEI 3002277609

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 14, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sejong (Korea (the Republic of))

Facility

Other inspections at this facility

  • 1112744 (VAI Fri Dec 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036107 (VAI Fri Nov 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 964103 (VAI Fri Mar 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 773981 (VAI Fri Mar 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
183321 CFR 211.84(d)(1)Identity Testing of Each Component
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
360921 CFR 211.160(b)(2)In-process sample representation/identification
441821 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination