Datong Tongxing Antibiotics Co., Ltd.July 4, 2025

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

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Record Details

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.

Company: Datong Tongxing Antibiotics Co., Ltd.
Inspection Date: July 4, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
People: WenNing Chan
Wen Ning Chan (Mathematical statistician)

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ID · 1b7f6275-b93b-4e3c-b7bf-a83a08da9556