FDA 483 - Suzhou Suncadia Biopharmaceuticals Co., Ltd. - January 06, 2025

Suzhou Suncadia Biopharmaceuticals Co. Ltd. received a Form 483 following an FDA inspection, citing significant deficiencies in its manufacturing processes. The observations primarily concern inadequate procedures for preventing microbiological contamination, including issues with media fill validation, environmental monitoring, and aseptic processing systems. Additionally, the firm was cited for deficiencies in visual inspection procedures and the calibration and validation of automatic and electronic equipment, indicating a moderate level of severity regarding quality control and sterile manufacturing.