FDA 483 - Datong Tongxing Antibiotics Co., Ltd. - July 04, 2025

An FDA inspection of Datong Tongxing Antibiotics Co., Ltd. in Datong, China, an API drug manufacturer, revealed significant deficiencies in their Batch Production Records. The firm failed to adequately prepare production and control records for API intermediate batches, specifically lacking detailed descriptions for raw material quantities and labeling steps. These issues indicate a failure to maintain proper documentation for drug manufacturing processes.