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1271803

HK Kolmar Canada, Inc. — FEI 3002647523

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 5, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Barrie (Canada)

Facility

Other inspections at this facility

  • 1114552 (VAI Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027545 (VAI Fri Sep 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940515 (VAI Fri Aug 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853300 (NAI Fri Sep 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
194221 CFR 211.180(e)Records reviewed annually
200921 CFR 211.188Prepared for each batch, include complete information
202821 CFR 211.192Extent of discrepancy, failure investigations