SQA

OCTOBER 18, 2024

The establishment’s document control/record management system was not sufficient. The establishment did not always perform a physical exam on the directed donors in accordance with the directive. The establishment did not use appropriate and effective tests for infectious disease testing set out in the directive.

FDA 52

FDA Compliance Public Health World Health 52

SQA

OCTOBER 18, 2024

The establishments document control/record management system was not sufficient. The establishment did not always perform a physical exam on the directed donors in accordance with the directive. The establishment did not use appropriate and effective tests for infectious disease testing set out in the directive.

FDA 40

FDA Compliance Public Health Governance 40

SQA

JUNE 3, 2024

A health professional, in the context of a directed donation, did not create a document stating that, in their medical opinion, the use of sperm or ova would not pose a serious risk to human health and safety. Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules.

FDA 40

FDA COVID-19 Licensing Nurses 40