Remove 2028 Remove Hospitals Remove Records Management
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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. The deadline to submit feedback for this plan is 25 July 2024.

FDA 52
article thumbnail

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. The deadline to submit feedback for this plan is 25 July 2024.

FDA 40