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1232099

Acella Pharmaceuticals, LLC — FEI 3006691461

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 18, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Alpharetta, GA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1197977 (VAI Fri Feb 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152922 (OAI Fri Sep 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115488 (OAI Tue Jan 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085822 (VAI Fri Mar 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014708 (VAI Wed Mar 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports
683221 CFR 314.80(c)(2)Late submission of annual safety reports
891221 CFR 314.81(b)(2)Timely submission