FDA 483 - CSL Plasma Inc. - February 12, 2020

CSL Plasma, Inc. in New Hope, MN, was inspected for its Source Plasma operations, revealing significant issues with donor eligibility determination. The firm failed to clarify donor responses or obtain omitted information within 24 hours for multiple donors screened with incorrect gender-specific health history questionnaires or incomplete screenings. Additionally, the company failed to submit required biological product deviation reports for these affected units.