FDA 483 - Shouguang Fukang Pharmaceutical Co., Ltd. - February 21, 2025

Shouguang Fukang Pharmaceutical Co., Ltd. in Shouguang City, China, an API manufacturer, was cited for significant deficiencies across its quality control, manufacturing, and laboratory operations. Issues included inadequate data integrity practices, poor equipment cleaning and maintenance leading to contamination risks, and a lack of established critical process controls and analytical method validation. The inspection also highlighted unsanitary storage conditions, improper sample handling, and failures in aseptic technique during microbial testing.