CSL Plasma Inc.June 15, 2023

FDA 483 - CSL Plasma Inc. - June 15, 2023

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CSL Plasma Inc. in Henrico, VA, a plasma center, was cited for failing to thoroughly investigate unexplained discrepancies during an FDA inspection. The firm did not investigate 27 temperature readings that exceeded the set point for a freezer used to store collected plasma. This indicates a lapse in adherence to established work instructions for temperature excursions and quality control.

Company: CSL Plasma Inc.
Inspection Date: June 15, 2023
Product Type: Biologics
Office: Office of Regulatory Affairs
Person: Charles D. Boison

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ID · 90dd5a9b-d009-49b3-8022-07d017023311