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1272585

ALK-Abello, Inc. — FEI 3006900385

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 13, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Plainville, CT (United States)

Facility

Other inspections at this facility

  • 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))
  • 1025749 (VAI Tue Sep 19 2017 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
126321 CFR 211.68(b)Computer control of master formula records
142121 CFR 211.42(c)(10)Aseptic Processing Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
180921 CFR 211.160(a)Following/documenting laboratory controls
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls