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Donor sperm and ova inspections

Inspection report card summary

Initial inspection deficiencies report
Establishment name Reference number Inspection start date Inspection type Inspection rating
Fertilys Inc. 39B06511 2024-10-28 Re-Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
143- Quality Management System
  • The establishment’s quality management system did not meet some of the requirements of the Regulations.
  • The establishment’s document control or records management system was not sufficient.
245- Quality Management System
  • The establishment did not establish and maintain an internal audit system.
352- Labelling and Storing
  • The establishment did not always store sperm and ova at a temperature within the established acceptable storage temperature range.
458- Personnel, Facilities, Equipment and Supplies
  • Critical supplies were not always stored under proper environmental conditions.
567- Errors and Accidents
  • The establishment or health professional did not submit reports to the Minister for an investigation it conducted into a suspected error or accident that could lead to an adverse reaction.
644- Quality Management System
  • The standard operating procedures did not meet some of the requirements.
  • Some processes were not described in standard operating procedures.
753- Personnel, Facilities, Equipment and Supplies
  • The establishment did not have a program for the initial and ongoing training of some personnel and for evaluating their competency.
884- Records
  • The establishment’s records were not always accurate, complete, legible and/or indelible.

Inspection outcome

The inspection resulted in a compliant rating. The establishment was compliant with the Safety of Sperm and Ova Regulations.

The rating is the result of observations made by Health Canada based on a reasonable belief at a particular point in time during the course of an inspection that the establishment was conducting the regulated activities in compliance with the Safety of Sperm and Ova Regulations.

Measures taken by Health Canada

  • We requested corrective actions.
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