483
CSL Plasma Inc.FDA 483 - CSL Plasma Inc. - June 15, 2023
Record Details
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.
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ID · 90dd5a9b-d009-49b3-8022-07d017023311