FDA 483 - Suzhou Suncadia Biopharmaceuticals Co., Ltd. - January 06, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · db6d8e6c-6a2a-422c-9d7d-4543c46fad07