483
CSL Plasma Inc.CSL Plasma Inc. – FDA 483, Feb 7, 2025
Record Details
CSL Plasma Inc. in Union, SC, was inspected from February 3-7, 2025, and received one observation regarding inadequate laboratory controls. The firm failed to establish scientifically sound specifications and test procedures for raw materials, leading to the use of contaminated Sodium Citrate in drug products that were subsequently distributed. This lapse in vendor qualification and material testing resulted in product quality issues and required extensive recovery and quarantine actions.
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ID · 96860fea-6bc3-4102-8624-3b54729a3ae6
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