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

During an inspection conducted from April 21-25, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to Shanghai SynTheAll Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in Shanghai, China. The inspection revealed three significant observations indicating deficiencies in their quality system.

The first observation concerned the quality control unit's failure to implement proper change controls and timely corrective actions. Specifically, 55 written procedures were not fully converted from their old tracking system to a new electronic system, leading to outdated procedure references being reviewed and approved. Secondly, the FDA noted that samples of raw materials, intermediates, and finished APIs were not representative, as existing sampling procedures lacked specific details for collecting random and representative samples. Finally, the inspection identified deficiencies in environmental monitoring within API processing areas, where Grade D Classified areas were not monitored under dynamic conditions for airborne particulate matter, relying instead on static condition monitoring.

Shanghai SynTheAll Pharmaceutical Co., Ltd. is responsible for addressing these observations by identifying and correcting violations of quality system requirements to ensure compliance with regulatory standards for API manufacturing.