FDA 483 - Fujian Genohope Biotech Ltd. - January 16, 2026
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Fujian Genohope Biotech Ltd., an API and sterile drug manufacturer, received a Form 483 for significant deficiencies in its cleaning validation program, including missing test results and visible residues on equipment. The firm also lacked appropriate controls over computer systems, specifically regarding the backup of quality manufacturing data without proper oversight or documentation. These observations indicate a need for improved quality control and data integrity practices.
ID · 3e0cb306-9e79-42ae-9d06-be81f412b193