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1228759

Delpharm Boucherville Canada, Inc. — FEI 3000280957

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 26, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Boucherville (Canada)

Facility

Other inspections at this facility

  • 1121358 (NAI Tue Feb 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057031 (NAI Tue Jun 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982638 (NAI Tue Aug 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 855260 (VAI Tue Oct 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 743413 (OAI Thu Aug 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
119421 CFR 211.42(c)Defined areas of adequate size for operations
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products