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FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

INSPECTION TRACKER: DRUG MANUFACTURING ESTABLISHMENTS (CANADA)

April 7, 2015 By Barry Friedman Leave a Comment

Health Canada Begins Publishing Information Regarding Emerging Issues

As part of Health Canada’s ongoing commitment to openness and transparency, the Department recently began publishing information regarding emerging issues identified through the drug inspection program.

This Inspection Tracker provides a snapshot of the potential health and safety issues Health Canada is tracking with companies that fabricate, package/label, test, wholesale, distribute or import drugs for sale in Canada. The information in the chart will expand to eventually include details about affected Canadian companies and products.

How the Inspection Tracker Works

  1. Health Canada responds to potential risks as soon as they learn about them whether from their own inspections, the companies themselves, adverse reaction reports or from various regulatory partners.
  2. The tracker highlights actions Health Canada is taking such as: requests for voluntary quarantine, stop sales, import restrictions, or product recalls. It also indicates those circumstances where no action has been warranted.
  3. Even if a company is listed on the tracker, it doesn’t necessarily mean there is an immediate risk to the health of Canadians. It means Health Canada is looking into a potential issue.
  4. Health Canada will continue to take action to manage risks identified to the health of Canadians using the most appropriate level of intervention, proportional to the risk to health.
  5. This tracker currently doesn’t list specific drugs and health products affected but links to Recalls & Safety Alerts if a risk has been linked to specific products on the Canadian market.
  6. This tracker is updated regularly.

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Filed Under: New Guidances for Industry, Regulatory Compliance Tagged With: drug inspection program, Health Canada, import bans, Inspection Tracker, risk identification, stop sales, voluntary recalls

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