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1070323

Alk-abello, Inc. — FEI 2431784

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 30, 2018
Fiscal Year
2019
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Port Washington, NY (United States)

Facility

Other inspections at this facility

  • 1220460 (VAI Tue Oct 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1202393 (VAI Thu Mar 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002541 (VAI Wed Dec 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871138 (VAI Tue Feb 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 780215 (VAI Wed Mar 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products