Inspectorate Program: Annual Inspection Summary Report 2012-2013

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The Annual Inspection Summary Report outlines inspection activities conducted by Health Canada's Inspectorate Program for the fiscal year 2012-2013.

Highlights of the report:

• Results and observations from inspection activities are summarized by product line and/or inspection type.
• Frequent observations explained and listed according to the related regulatory requirement(s).
• Health Canada conducted 1,257 inspections, made hundreds of observations requiring corrective actions, and issued 37 non-compliant (NC) ratings.  A non-compliant (NC ) rating is given when the regulated party has not demonstrated that the activities it conducts are in compliance with the Food and Drugs Act and its associated Regulations.

This document reflects Health Canada's commitment to making compliance information readily available to industry stakeholders, both to demonstrate the effectiveness of our inspection programs, and to reveal how affected parties are complying with the regulations.

Health Canada's Inspectorate plays a key role in maintaining the safety of health products in the Canadian marketplace. Regulated parties are responsible for complying with the Food and Drugs Act and associated Regulations as mandated by Health Canada's Health Products and Food Branch (HPFB) and Regions and Programs Bureau (RAPB). When non-compliance is identified, Health Canada takes appropriate compliance and enforcement actions.