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1080852

Haw Par Healthcare Limited — FEI 3001432470

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 1, 2019
Fiscal Year
2019
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))
  • 1177852 (OAI Fri Aug 19 2022 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
109821 CFR 211.22(c)Approve or reject procedures or specs
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
144821 CFR 211.111Establishment of time limitations
163221 CFR 211.130(c)Lot or control number assigned
200821 CFR 211.186(a)Written procedures followed
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
356521 CFR 211.58Buildings not maintained in good state of repair
360321 CFR 211.160(b)Scientifically sound laboratory controls
430621 CFR 211.80(a)Written Procedures Not Followed
436021 CFR 211.170(b)Reserve drug product sample quantity - all tests