FDA EIR - Chengda Pharmaceuticals Co., Ltd. - November 15, 2024

An FDA surveillance inspection of Chengda Pharmaceuticals Co., Ltd., located in Jiaxing, Zhejiang, China, was conducted from November 11 to November 15, 2024. This announced inspection focused on the firm's manufacturing of finished Active Pharmaceutical Ingredients (APIs) by chemical synthesis for human drug products destined for the U.S. market. The inspection was carried out under compliance program 7356.002F, "Active Pharmaceutical Ingredient (API) Process Inspections," utilizing ICH Q7, "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients," as a guiding framework. During the inspection, key operational systems including Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Control were thoroughly reviewed. Notably, previous FDA-483 observations from a March 2016 inspection, which cited a lack of control procedures for manufacturing processes and insufficient written procedures for equipment maintenance, were verified as adequately corrected. For the current inspection, no new inspectional observations were issued, and no samples were collected. The firm management was cooperative throughout the process. Consequently, the inspection was classified as "No Action Indicated (NAI)," indicating no significant compliance issues requiring immediate regulatory action, with only routine follow-up anticipated. The firm’s registration remains current.