971066

Bora Pharmaceuticals Laboratories, Inc — FEI 3007184570

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 15, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Miaoli County (Taiwan)

Citations

IDCFRDescription
191221 CFR 211.166(a)Written program not followed
358521 CFR 211.110(a)Control procedures to monitor and validate performance