You will need to provide the TGA with recall progress reports at:

• 2 weeks (initial report)
• for human blood and blood components only: final report at 4 weeks
• 6 weeks (follow-up report)
• 3 months or at another agreed time (final report).

Produce the progress reports using the templates that the TGA provides you with your agreement letter. Submit the progress reports by email.

For human blood and blood components, provide a single report at 4 weeks.

Include in your reports:

• the TGA recall reference number (structured RC-201X-RN-XXXXX-X)
• effectiveness of recall
• whether the investigation changed the scope of the recall
• information about root cause of the deficiency and corrective and preventative action taken to prevent recurrence of the issue.

You are not required to repeat information that you have provided in a previous report, unless there is a change to that information.

The level of information in your reports should be sufficient for the TGA to analyse the effectiveness of the recall (Step 13). If the TGA is concerned about an aspect of your recall, it will follow this up with you.

Initial report (2 weeks)

You need to submit your initial report to the TGA at the agreed time, usually two weeks after recall implementation.

Include in your initial report information about:

• dates when parts of the recall strategy were implemented, such as when the sponsor's customer letter was sent
• descriptions of any major impediments, such as the recall or corrective actions not progressing according to agreed timelines
• implications of initial investigation findings for the scope of the recall action, such as whether additional units or products have been identified with the same defect
• for products exported from Australia, whether overseas suppliers have been informed of the recall action being undertaken in Australia.

Human blood and blood components report (4 weeks)

Recalls of blood and blood components have a 4-week close out. You need to complete a final report, but not a follow-up report.

Include details about the:

• fate of the components
• root cause investigation
• corrective and preventative actions implemented.

Follow-up report (6 weeks)

You need to submit your follow-up report to the TGA at the agreed time, usually six weeks after recall implementation.

Include in your follow-up report information about:

• percentage of customers that you contacted who have responded to your requested recall action:
  • have customers confirmed the amount of affected product held (including none)?
  • have they agreed to the recall or corrective action?
• percentage of customers who have returned or destroyed their affected units
• identification of customers with units 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 to the TGA at the agreed time, usually three months after recall implementation.

Include in your final report information about:

• percentage of stock that has been returned
• percentage of returned stock that has been destroyed or disposed: include a certificate of destruction if products are destroyed
• percentage of customers with units that have been corrected, or percentage of customers that have been supplied with the correction
• your root cause analysis of the deficiency that led to the recall action
• proposed CAPA to prevent the recurrence of the defect that led to the recall action.