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

During an inspection conducted from November 30 to December 14, 2023, the FDA identified significant Good Manufacturing Practice (GMP) violations at Suzhou Suncadia Biopharmaceuticals Co., Ltd., a drug substance and drug product manufacturer located in Suzhou, China. The inspection revealed multiple deficiencies across critical operational areas.Key issues included inadequate aseptic processing controls, such as frequent high-risk interventions on the vial fill line without proper decontamination or documentation, and the use of non-sterile tools. The firm also exhibited widespread data integrity failures, including manual integration of HPLC data without clear procedures, unprotected laboratory equipment, lack of electronic raw data backup, unauthorized use of administrator accounts, and insufficient Quality Assurance review of electronic records and audit trails.Further observations highlighted a failure in quality unit responsibilities, with drug substances being processed before final release. Visual inspection procedures were deemed insufficient, and capping validation data for container closure integrity was inadequate. The company also lacked scientifically sound controls for manufacturing operations, leading to unaddressed deviations like abnormal air pressure and equipment failures, and had deficiencies in raw material management, including the use of market-specific materials interchangeably.These findings indicate a need for comprehensive corrective actions to align Suzhou Suncadia Biopharmaceuticals Co., Ltd.'s operations with regulatory expectations, ensuring drug product quality, purity, and safety.