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Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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Step 11. Reviewing the recall

Components of the review

The TGA examines your progress reports to:

  • verify you have:
    • completed all the agreed actions with documented evidence
    • justified any discrepancies or inconsistencies
    • provided evidence of the fate of the final goods
  • determine whether the following are satisfactory:
    • implementation of the recall
    • the investigation of the issue or hazard that prompted the recall and the root cause identification
    • CAPAs implemented to prevent or minimise recurrence of the issue in the future
  • assess the effectiveness of the recall action
  • assess ongoing compliance with regulatory requirements.

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

Outcomes of the review

Possible outcomes of our review include:

  1. Actions and information provided is satisfactory:
    • TGA issues 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.
  2. Nature of the root cause or remedial are not apparent:
    • TGA may request additional information, including full CAPA reports for review.
  3. Effectiveness of the recall is not satisfactory:
    • TGA will follow-up with you to determine additional action to ensure the recall is effective.
  4. 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, after further investigation, cancel, suspend, or impose requirements on, the relevant ARTG entries.

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