483
CSL Plasma Inc.FDA 483 - CSL Plasma Inc. - November 22, 2019
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Record Details
CSL Plasma Inc. in Toledo, OH, was cited for two observations during an FDA inspection. The firm failed to provide illiterate donors with required audio educational materials on subsequent visits, impacting numerous plasma donations. Additionally, the company failed to submit a biological product deviation report concerning this issue, despite processing units from the affected donors.
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ID · 4ebc59f3-6ba1-4433-a26f-4c9cf1fe69db