FDA 483 - Taixing SynTheAll Pharmaceutical Co., Ltd - September 27, 2024

An FDA inspection of Taixing SynTheAll Pharmaceutical Co., Ltd. revealed significant deficiencies in their manufacturing processes for Active Pharmaceutical Ingredients (API). The firm failed to qualify raw material suppliers, establish method validation programs, and implement a cleaning validation program for equipment. Additionally, equipment performance qualifications were inadequate, and a Master Batch Record for API production was absent, indicating systemic quality control issues.