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1152922

Acella Pharmaceuticals, LLC — FEI 3006691461

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 17, 2021
Fiscal Year
2021
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))
  • 1197977 (VAI Fri Feb 10 2023 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
104921 CFR 211.22(a)Approve or reject components, products
111121 CFR 211.25(a)Training , Education , Experience overall
135821 CFR 211.100(b)SOPs not followed / documented
202721 CFR 211.192Investigations of discrepancies, failures
438921 CFR 211.198(a)Procedures to be written and followed