928851

Navidea Biopharmaceuticals Inc — FEI 3009548429

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 21, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Dublin, OH (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports