FDA 483 - GenIbet Biopharmaceuticals, S.A. - January 21, 2025

GenIbet Biopharmaceuticals, S.A. in Oeiras, Lisbon, Portugal, a biological drug product manufacturer, was inspected by the FDA. The inspection revealed deficiencies in complaint handling procedures, specifically the failure to maintain written records for drug product complaints. Additionally, the firm lacked established written procedures for annual evaluations and reviews of all investigations conducted for drug products, particularly for VOWST®.