FDA 483 - RAPHA Health Network International, Inc. - December 16, 2022

An FDA inspection of BAPHA Health Network International, Inc., an OTC drug repackager/relabeler in Doral, FL, revealed significant deficiencies in quality control, supplier qualification, deviation management, and batch record documentation. The firm failed to adequately test incoming components, qualify suppliers, investigate deviations, and maintain complete batch production records. These issues indicate a lack of robust quality systems for drug product manufacturing and control.