FDA 483 - Zhejiang Bamboo Pharmaceuticals Co., Ltd. - September 27, 2024

Zhejiang Bamboo Pharmaceuticals Co., Ltd. in Shangyu District, China, was cited for significant deficiencies in its quality control and equipment cleaning practices. The firm failed to adequately investigate out-of-specification results and production deviations, lacking complete documentation and comprehensive root cause analysis. Additionally, equipment used in API and intermediate production was not properly cleaned or stored, leading to potential contamination and product quality issues.