FDA 483 - Shanghai SynTheAll Pharmaceutical Co., Ltd. - April 25, 2025

Shanghai SynTheAll Pharmaceutical Co., Ltd., an API manufacturer in Shanghai, China, was cited for three observations during an FDA inspection. The firm failed to implement proper change controls and corrective actions for its electronic procedure system, lacked detailed and specific methods for collecting representative samples of materials, and performed environmental monitoring for airborne particulate matter under static instead of dynamic conditions in classified processing areas. These issues indicate deficiencies in quality control, sampling procedures, and environmental monitoring systems.