FDA 483 - Fujian Genohope Biotech Ltd. - June 02, 2023

Fujian Genhope Biotech Ltd, a sterile manufacturer in Putian, China, was cited for significant deficiencies across its manufacturing operations. Observations included failure to follow written procedures for component handling, inadequate equipment qualification and use, poor electronic data integrity practices, and insufficient production and process controls. These issues indicate a systemic lack of adherence to good manufacturing practices, potentially impacting product quality and safety.