1102837

APIPHARMA d.o.o — FEI 3010235999

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 26, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Nasice (Croatia)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
356721 CFR 211.84(d)(2)Component identification test