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1259373

Bora Pharmaceutical Services Inc. — FEI 3002807086

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 28, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mississauga (Canada)

Facility

Other inspections at this facility

  • 1116737 (NAI Thu Nov 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030562 (NAI Fri Sep 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 937006 (NAI Fri Jul 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 937000 (NAI Tue Jul 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 852228 (NAI Wed Sep 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
154021 CFR 211.125(a)Strict control not exercised over labeling issued
188321 CFR 211.165(a)Testing and release for distribution
191221 CFR 211.166(a)Written program not followed
192221 CFR 211.166(a)(4)Testing in same container - closure system
202621 CFR 211.192Quality control unit review of records
203421 CFR 211.194(d)Laboratory equipment calibration records
432821 CFR 211.122(a)Written procedures not followed
436921 CFR 211.188(b)(11)Identification of persons involved, each significant step