Audits and inspections frequently asked questions

1. How might I be identified for an audit?

Audits are targeted activities where entities are identified for audit through an assessment of non-compliance risk. Risk is identified using a variety of considerations such as historical regulatory information, intelligence and the number and type of registrations, approvals and permits held by a particular entity.

2. Will it cost me anything if I am selected for an audit?

No.

3. What sort of things will be audited?

Audits will assess the level of compliance with conditions attached to product registration, active approval and APVMA permits.

4. Will I be notified of an audit?

The APVMA will be in direct contact with you to advise of a planned audit activity. If you are not contacted you have not being selected for an audit.

5. How do I respond to an audit request?

If you are directly notified by the APVMA that you have been selected for an audit, an APVMA Officer will guide you through what is required, including how to respond to an audit request.

6. Will I need to attend the APVMA Offices for an audit?

No.

7. What can I expect at the end of an audit?

The Auditee will be involved in the finalisation of the audit report and will be provided with a final copy. Any non-compliance will be identified and it will be expected that any identified non-compliance will be rectified as quickly as possible by the Auditee.

If significant non-compliance is found it may be referred for formal investigation.

8. What if I have concerns about an audit?

If you have concerns about participating in an audit you should, in the first instance, contact the APVMA Officer working on the audit.

The APVMA is committed to conducting compliance audits to a high standard of professionalism.

We will endeavour to help you understand the reason for the audit and the outcome of our audit activity. We will also give you the opportunity to respond to any audit findings.