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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
Tripod Medical Incorporated 5C1F7ED4 2021-12-08 Regular Inspection Compliant

Summary of observations

Observation number Regulation Summary of observation
125- Donor Suitability Assessment
  • The establishment did not always use appropriate and effective tests for infectious disease testing set out in the Guidance Document.
243- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
343- Quality Management System
  • Some standard operating procedures were not always followed.
444- Quality Management System
  • Some processes were not described in standard operating procedures.
544- Quality Management System
  • Some standard operating procedures were not kept up to date.
653- 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.
784- 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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