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1112744

Sinsin Pharmaceutical Co., Ltd. — FEI 3002277609

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 13, 2019
Fiscal Year
2020
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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls