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1014708

Acella Pharmaceuticals, LLC — FEI 3006691461

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 8, 2017
Fiscal Year
2017
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

  • 1232099 (VAI Wed Dec 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Recent compliance actions

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
683021 CFR 314.80(c)(2)Interval
891221 CFR 314.81(b)(2)Timely submission