FDA 483 - SUNNY PHARMTECH INC. - November 04, 2022

An FDA inspection of SUNNY PHARMTECH INC in Taoyuan City, Taiwan, a drug and API manufacturer, revealed significant deficiencies in quality control. The firm failed to establish procedures to prevent objectionable microorganisms, maintain and clean equipment adequately, and ensure proper batch production and equipment maintenance records. These issues indicate a lack of robust quality systems, posing potential risks to drug product safety and quality.