Chengdu Shengnuo Biopharm Co Ltd – FDA 483, Aug 27, 2026

Chengdu Shengduo Biopharm Co., Ltd., an API manufacturer in Dayi Country, China, was cited for numerous significant Good Manufacturing Practice (GMP) violations during an FDA inspection. These issues include inadequate test method validation, insufficient process validation, poor facility and equipment cleanliness, critical equipment maintenance failures, and a systemic breakdown in quality unit oversight and investigations. The findings indicate a severe lack of control over manufacturing processes, potentially compromising the quality, safety, and purity of their APIs.