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773981

Sinsin Pharmaceutical Co., Ltd. — FEI 3002277609

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 2, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sejong (Korea (the Republic of))

Facility

Other inspections at this facility

  • 1261013 (VAI Fri Feb 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
144821 CFR 211.111Establishment of time limitations
358321 CFR 211.110(a)Written in-process control procedures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls