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1141073

ALK-Abello, Inc. — FEI 3006900385

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 3, 2021
Fiscal Year
2021
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))
  • 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
117421 CFR 211.42(b)Product flow through building is inadequate
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
202721 CFR 211.192Investigations of discrepancies, failures
355521 CFR 211.48(b)Drains--Size, Back-siphonage Prevention