974315

Haw Par Healthcare Limited — FEI 3001432470

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 26, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Singapore (Singapore)

Citations

IDCFRDescription
154021 CFR 211.125(a)Strict control not exercised over labeling issued
188321 CFR 211.165(a)Testing and release for distribution
356221 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action