FDA 483 - CSL Plasma Inc. - February 07, 2025

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.