FDA 483 - CSL Plasma Inc. - August 05, 2019

CSL Plasma, Inc. in Philadelphia, PA, was cited for significant deficiencies in donor screening and eligibility determination processes, including the use of incorrect gender-specific health history questionnaires. The inspection also revealed a failure to thoroughly investigate a trend of plasma overharvests and a failure to submit required biological product deviation reports. These issues indicate serious concerns regarding donor safety and product quality control.