FDA 483 - CSL Plasma Inc. - August 30, 2019

An FDA inspection of CSL Plasma, Inc. in Mechanicsburg, PA, revealed significant deficiencies in donor screening and eligibility determination for source plasma collection. The firm repeatedly failed to use correct gender-specific health history questionnaires, leading to inadequate risk factor assessment and improper donor eligibility. Additionally, the inspection found failures in thoroughly investigating discrepancies, reporting biological product deviations, maintaining complete records, and adhering to established standard operating procedures, all of which could impact the safety and quality of distributed plasma products.