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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The establishment’s document control/record management system was not sufficient. Wholesalers and hospitals with an existing inventory of any of the lots being recalled should discontinue use, stop distribution, and quarantine the product immediately.

FDA 52
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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The establishments document control/record management system was not sufficient. Wholesalers and hospitals with an existing inventory of any of the lots being recalled should discontinue use, stop distribution, and quarantine the product immediately.

FDA 40
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SQA Regulatory Surveillance Summary for January and February 2024

SQA

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