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483
•CSL Plasma Inc.•November 22, 2019

CSL Plasma Inc. – FDA 483, Nov 22, 2019

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.

Company
CSL Plasma Inc.
Inspection date
November 22, 2019
Product type
biologics
Office
Cincinnati District Office
Person
  • Lauren M. Lilly (Compliance Officer at FDA)
View Company Profile

ID · 4ebc59f3-6ba1-4433-a26f-4c9cf1fe69db

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