483
CSL Plasma Inc.FDA 483 - CSL Plasma Inc. - May 02, 2019
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Record Details
CSL PLASMA in Philadelphia, PA, was inspected from April 16 to May 2, 2019, revealing a significant issue regarding the presence of medical staff. The firm failed to ensure a responsible physician or physician substitute was on the premises during critical donor eligibility determinations and blood collection activities. This indicates a lapse in direct medical oversight for source plasma operations.
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ID · a2097c05-4ae8-4d4a-9480-bdb4b16580fd