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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
ReproMed Ltd. 24A3836F 2021-03-22 Remote 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.
257- Personnel, Facilities, Equipment and Supplies
  • The establishment did not ensure that some critical equipment was validated, calibrated, cleaned or maintained as required.
323- Donor Suitability Assessment
  • The establishment’s structured donor screening questionnaire(s) did not include some criteria outlined in the Directive.
443- Quality Management System
  • The establishment’s document control or records management system was not sufficient.
544- Quality Management System
  • Some processes were not described in standard operating procedures.
644- Quality Management System
  • Some standard operating procedures were not kept up to date.
753- 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.
859- Errors and Accidents
  • The establishment’s system for error and accidents did not meet some of the requirements.
969- Adverse Reactions
  • The establishment’s system for adverse reactions did not meet some requirements.
1084- 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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