483
CSL Plasma, Inc.CSL Plasma, Inc. – FDA 483, Jul 20, 2026
Record Details
CSL Plasma Inc. in Rochester, NY, was inspected regarding its source plasma operations and received one observation. The firm was cited for inadequate staffing levels during apheresis collection, specifically failing to meet the required phlebotomist-to-donor ratio outlined in their standard operating procedures. This deficiency raises concerns about the safety, purity, potency, identity, and effectiveness of the final product.
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ID · b3d82547-728a-401a-8e25-777100a8fb37
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