927965

Apotex Inc. — FEI 3002906944

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 11, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
North York (Canada)

Citations

IDCFRDescription
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports