1085822

Acella Pharmaceuticals, LLC — FEI 3006691461

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 29, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Alpharetta, GA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
683221 CFR 314.80(c)(2)Late submission of annual safety reports
891221 CFR 314.81(b)(2)Timely submission