About donor semen inspections

Note:
The information on this page will change as a result of the new Safety of Sperm and Ova Regulations under the Assisted Human Reproduction Act coming into force in February 2020. For more information visit the Assisted Human Reproduction web page.

Canada aims to minimize the potential risk of passing on infections and diseases through the use of donor semen for assisted conception. Learn how we conduct inspections of donor semen establishments.

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Donor semen inspections

In Canada, donor semen establishments are regulated by the:

This act and its regulations on semen allow us to:

  • assess whether an establishment is complying with all of its regulatory requirements
  • monitor donor semen establishments that process, import or distribute donor semen for use in assisted conception

Any establishment governed by the regulations on semen may be inspected at any time by the federal government.

What does processing donor semen mean?

Processingdonor semen can include:

  • storing
  • testing
  • labelling
  • collecting
  • preparing
  • preserving

What inspectors look for

During an inspection, our inspectors:

  • review the establishment's:
    • records
    • procedures
    • documents
  • assess compliance, such as donor screening for imported semen

Inspectors make "observations" when they note areas where the establishment is not meeting regulatory requirements. Each observation is classified by level of risk.

After a donor semen inspection

After completing an inspection, the inspector creates a report that:

  • documents the findings
  • communicates the observations to the establishment
  • issues an overall inspection rating to the establishment

The overall rating indicates whether the establishment is compliant or non-compliant with the:

  • Food and Drugs Act
  • Processing and Distribution of Semen for Assisted Conception Regulations

The rating is based on:

  • the number of observations noted by the inspector
  • risk level of each observation

Compliant rating

A compliant rating means the establishment is complying with the Food and Drugs Act and the regulations on semen.

An establishment may receive a compliant rating even if a number of observations have been identified. This is because the rating also takes into consideration the level of risk.

Establishments will need to take corrective actions to address any observations.

Non-compliant rating

A non-compliant rating means that the establishment:

  • has not shown that its activities comply with the Food and Drugs Act and regulations on semen
  • needs to take immediate corrective actions

In the case of a non-compliant rating, we may request recalls and issue public advisories.

Ongoing follow-up

Establishments must take corrective actions to address the observations either during the inspection or after it. They must provide us with a written corrective action plan for any observations identified, including target dates for completion.

We may conduct a follow-up inspection to make sure the corrective actions have been taken.

When needed, we will consider further enforcement actions, as outlined in the Compliance and Enforcement Policy (POL-0001).

Inspection report cards

Canada posts detailed report cards for donor semen inspections. Each report card summarizes the inspection observations and ratings:

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