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

Additional findings included concerns with respect to document control, records management, and lack of compliance with Standard Operating Procedures (SOPs). FDA has prepared a draft document entitled Food and Drug Administrations Draft Report and Plan on Best Practices for Guidance.

FDA 40

FDA COVID-19 Licensing Nurses 40