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1177852

Haw Par Healthcare Limited — FEI 3001432470

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 19, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Singapore (Singapore)

Facility

Other inspections at this facility

  • 1250188 (VAI Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080852 (OAI Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 974315 (VAI Thu May 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873440 (VAI Fri Mar 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 633558 (OAI Thu Oct 29 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
144821 CFR 211.111Establishment of time limitations
191421 CFR 211.166(a)Lack of written stability program
358521 CFR 211.110(a)Control procedures to monitor and validate performance
434221 CFR 211.142(b)Storage under appropriate conditions
457621 CFR 211.192No written record of investigation