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925072

MSD International GmbH (Singapore Branch) — FEI 3004611169

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 17, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Singapore (Singapore)

Facility

Other inspections at this facility

  • 1109025 (NAI Thu Sep 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008993 (VAI Thu Mar 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 824017 (VAI Tue Mar 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 674861 (NAI Fri Jul 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
181021 CFR 211.160(a)Lab controls established, including changes
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
358521 CFR 211.110(a)Control procedures to monitor and validate performance