Home / Inspections / 1197977

1197977

Acella Pharmaceuticals, LLC — FEI 3006691461

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 10, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Alpharetta, GA (United States)

Facility

Other inspections at this facility

  • 1232099 (VAI Wed Dec 18 2024 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
109821 CFR 211.22(c)Approve or reject procedures or specs
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
438921 CFR 211.198(a)Procedures to be written and followed