CSL Plasma Inc.July 18, 2019

FDA 483 - CSL Plasma Inc. - July 18, 2019

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Record Details

During an inspection from July 11-18, 2019, CSL Plasma Inc. in Columbus, OH, was cited for a significant failure in its medical history assessment process. A donor who openly discussed heroin use was improperly screened and allowed to proceed to donation, indicating a serious lapse in preventing the collection of potentially unsafe plasma.

Company: CSL Plasma Inc.
Inspection Date: July 18, 2019
Product Type: Biologics
Office: Cincinnati District Office
Person: Jennifer L. Sheehan

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ID · 08008369-2b3d-47a1-953f-082757b40ca2