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DRAFT: Uniform Recall Procedure for Therapeutic Goods

Consultation document

27 October 2015

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Step 13 - Reviewing the recall action

Note: This information is part of the Consultation: Revised edition of the Uniform Recall Procedure for Therapeutic Goods

The TGA will examine your progress reports to:

  • verify that:
    • all the agreed actions were completed and documentary evidence was provided
    • any discrepancies or inconsistencies are justified
    • evidence of the fate of the final product has been provided.
  • determine whether the following are satisfactory:
    • implementation of the recall action
    • the investigation of the reason for the recall action and the root cause identification
    • CAPAs implemented to prevent or minimise the recurrence of the issue in the future
  • assess the effectiveness of the recall action
  • assess the ongoing compliance with regulatory requirements.

If the TGA is concerned about an aspect of the recall process, it will follow this up with you.

Outcomes of review

Possible outcomes of the TGA's review of the recall action include:

  • Actions and information provided is satisfactory:
    • TGA issue a close-out report to you stating that the recall actions were satisfactory and no additional actions are required at this stage
    • the information submitted will be used to inform manufacturer inspections and for trending purposes in product reviews.
  • Nature of the root cause or remedial action are not apparent:
    • TGA may request you submit additional information, including full CAPA reports, for review.
  • Effectiveness of the recall action is not satisfactory:
    • TGA will follow-up with you to determine what additional actions are required to ensure the effectiveness of the recall action.
  • Identification of a systemic or serious issue (at any stage of the recall process):
    • TGA may schedule an immediate inspection of the manufacturer
    • TGA may cancel or suspend or impose other requirements on the affected ARTG entries after further investigation.

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