FDA 483 - RAPHA Health Network International, Inc. - September 09, 2022

RAPHA Health Network International, Inc. in Doral, FL, a dietary supplement manufacturer, was inspected by the FDA from September 1-9, 2022. The inspection revealed significant deficiencies in their quality control, production, and laboratory operations, indicating a lack of adherence to good manufacturing practices for dietary supplements. Key issues included inadequate batch production records, failure to establish and follow specifications, and uncalibrated laboratory equipment.