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964103

Sinsin Pharmaceutical Co., Ltd. — FEI 3002277609

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 11, 2016
Fiscal Year
2016
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))
  • 773981 (VAI Fri Mar 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
192021 CFR 211.166(a)(3)Valid stability test methods
200321 CFR 211.184(c)Individual inventory record
359221 CFR 211.110(c)In-process materials characteristics testing
360321 CFR 211.160(b)Scientifically sound laboratory controls
431121 CFR 211.84(c)(4)Compositing of Sub Samples
434021 CFR 211.142Written warehousing procedures established/followed
440621 CFR 211.194(a)(2)Suitability of testing methods verified