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855260

Delpharm Boucherville Canada, Inc. — FEI 3000280957

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 22, 2013
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Boucherville (Canada)

Facility

Other inspections at this facility

  • 1228759 (VAI Fri Jan 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 743413 (OAI Thu Aug 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145121 CFR 211.113(b)Procedures for sterile drug products
202821 CFR 211.192Extent of discrepancy, failure investigations
360321 CFR 211.160(b)Scientifically sound laboratory controls
439921 CFR 211.186(b)(7)Theoretical yield statement including percentages
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration