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Recall procedure

Uniform recall procedure for therapeutic goods, V2.2

12 December 2019

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Step 10. Reporting on the recall

Produce progress reports using the templates we provide with your agreement letter.

Your reports should be sufficient for us to analyse the effectiveness of the recall in Step 11.

  • Don't repeat information from a previous report, unless there is a change.

If we are concerned about an aspect of your recall, we will follow this up with you.

Your reports

Include in your reports:

  • the TGA recall reference number (structured as follows: RC-20XX-RN-XXXXX-X)
  • effectiveness of the recall
  • whether the investigation changed the scope of the recall
  • root cause and CAPA taken to prevent recurrence of the problem.

Timeframes for reports

Submit the progress reports by email at:

  • 2 weeks (initial report)
  • 6 weeks (follow-up report)
  • 3 months or at another agreed time (final report).

Provide a single report at 4 weeks for human blood and blood components recalled due to process failure and transfusion transmitted bacterial infection.

The Blood Service provides the TGA with compiled lists monthly and trends quarterly basis for recalls triggered by Single Donor Notifications.

Initial report (2 weeks)

Submit your initial report at the agreed time, usually two weeks after the start of the recall.

Include:

  • Dates when parts of the recall strategy were implemented, e.g. when you sent the sponsor's customer letter.
  • Descriptions of any major impediments, such as the recall or corrective actions not progressing according to agreed timelines.
  • Implications of the initial investigation findings for the scope of the recall, (e.g. whether you or the manufacturer have identified any additional goods with the same issue.)
  • Whether you notified overseas suppliers of exported goods about the recall in Australia.

Follow-up report (6 weeks)

This follow-up report is not needed if the recall is completed within 6 weeks or if we agree it's not needed (e.g. small scale recall.)

Submit your follow-up report at the agreed time, usually six weeks after recall implementation.

Include:

  • Percentage of customers you contacted who have responded to your requested recall:
    • confirming the amount of affected goods held (including none)
    • agreeing to the recall or corrective action
  • Percentage of customers who returned or destroyed their affected goods
  • Identity of customers with goods requiring correction
  • Descriptions of any major impediments, such as the recall or corrective actions not progressing according to agreed timelines.

Final report (3 months or at another agreed time)

Submit your final report at the agreed time, usually three months after implementing the recall.

Include:

  • Percentage of:
    • returned goods
    • returned goods destroyed or disposed. Include a certificate of destruction for destroyed goods.
    • customers with goods that have been corrected, or supplied with the correction
  • Your root cause analysis that led to the recall
  • Proposed CAPA to prevent recurrence of the issue that led to the recall.

Human blood and blood components report (4 weeks)

Recalls of blood and blood components have a 4-week close out.

Complete a final report and include details about the:

  • fate of the components including any patient implications due to the transfusion of the affected components
  • root cause investigation
  • CAPA implemented.

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