FDA EIR - Suzhou Suncadia Biopharmaceuticals Co., Ltd. - January 06, 2025

A Food and Drug Administration (FDA) inspection of Suzhou Suncadia Biopharmaceuticals Co., Ltd. in Suzhou, China, was conducted from December 30, 2024, to January 6, 2025. This inspection, supporting drug substance and product manufacturing, followed a previous assessment in late 2023 which resulted in an Official Action Indicated (OAI) classification and a 10-item Form FDA-483. The current inspection focused on drug product and limited drug substance manufacturing areas, covering Quality, Production, Materials, Facilities and Equipment, and Laboratory Controls systems. It was conducted in accordance with CP 7346.832 for Pre-approval Inspections/Investigations and ICH Q7 Good Manufacturing Practice Guidance. At the conclusion of the inspection, a three-item Form FDA-483 was issued. The observations noted deficiencies in procedures designed to prevent microbiological contamination of sterile drug products, inadequate visual inspection procedures to assure drug product quality, and the absence of routine calibration, inspection, or checking for automatic or electronic equipment, including computer systems. Suzhou Suncadia Biopharmaceuticals Co., Ltd. committed to providing a written response to these observations within 15 business days. The initial field recommendation for this inspection is approval.