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1025749

ALK-Abello, Inc. — FEI 3006900385

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 19, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Plainville, CT (United States)

Facility

Other inspections at this facility

  • 1272585 (OAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1181903 (OAI Fri Oct 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1141073 (OAI Mon May 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073636 (NAI Thu Nov 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 892618 (VAI Tue Aug 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143321 CFR 211.42(c)(10)(iii)Air Supply
145121 CFR 211.113(b)Procedures for sterile drug products
180921 CFR 211.160(a)Following/documenting laboratory controls
354721 CFR 211.46(b)Equipment for Environmental Control
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified