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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
OriginElle Ottawa 99167980 2024-12-03 Re-Assessment Compliant

Summary of observations

Observation number Regulation Summary of observation
118- Notification
  • The establishment did not notify Health Canada before distributing or importing sperm or ova.
232- Directed Donation Process
  • The establishment did not always perform donor screening for directed donors in accordance with the requirements set out in the Directive.
343- Quality Management System
  • The establishment did not have standard operating procedures for some of the activities that it conducts.
443- Quality Management System
  • Some standard operating procedures were not always followed.
544- Quality Management System
  • Some standard operating procedures were not kept up to date.
645- Quality Management System
  • The establishment’s internal audit system did not meet some of the requirements.
751- Labelling and Storing
  • The establishment did not verify the integrity of the immediate containers and the shipping containers.
853- Personnel, Facilities, Equipment and Supplies
  • The establishment’s program for the initial and ongoing training of all personnel and for evaluating their competency was not sufficient.
957- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
1058- Personnel, Facilities, Equipment and Supplies
  • The expiry dates of critical supplies were not always observed.
  • Critical supplies were not always validated or qualified as applicable for their intended use.
1184- 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

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