FDA 483 - Suzhou Suncadia Biopharmaceuticals Co., Ltd. - December 14, 2023

Suzhou Suncadia Biopharmaceuticals Co., Ltd. was cited for significant deficiencies across its drug substance and drug product manufacturing operations, particularly concerning aseptic processing, data integrity, and quality control. The inspection revealed issues with high-risk interventions in the vial fill line, inadequate data management and system access controls, and failures in preventing microbiological contamination. These observations indicate a systemic lack of robust procedures and controls necessary to ensure product quality, sterility, and data reliability.