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Audit & Inspection Defense
Health Canada Inspection & Compliance Readiness
Health Canada inspections focus on the activities an establishment actually performs. A mature compliance system must demonstrate implementation through records, not only the existence of procedures.
Inspection Readiness Scope
MDEL inspection readiness assessment and gap analysis
Complaint file review, investigation rigor, and closure timeliness
Distribution-record and batch traceability stress-testing
Recall procedure validation and mock-recall drill execution
Mandatory problem reporting controls and MDR compliance checks
Labelling, IFU, and licence verification controls
Importer/distributor quality management agreements and audits
Corrective and preventive action (CAPA) evidence and root-cause analysis
Personnel training records, job descriptions, and qualification files
Response strategy for Health Canada inspection observations and non-compliances
Inspection Lens:
Procedure → Record → Regulatory Decision → Evidence of Implementation → Effectiveness
Simulate and Defend Your Health Canada Regulatory Audit
Our former auditors conduct mock inspections, stress-test complaint files, and prepare CAPA response packages.