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

Source: https://www.globalkeysolutions.net/records/483/datong-tongxing-antibiotics-co-ltd/1b7f6275-b93b-4e3c-b7bf-a83a08da9556

> FDA 483 for Datong Tongxing Antibiotics Co., Ltd. on July 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Datong Tongxing Antibiotics Co., Ltd.
- Inspection Date: 2025-07-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [WenNing Chan](https://www.globalkeysolutions.net/people/wenning-chan/973bf578-405d-46cf-b09e-254d6db07c08)
- [Mathematical statistician](https://www.globalkeysolutions.net/people/wen-ning-chan/e1f71810-6994-4474-876f-699ea9dee32c)

Company: https://www.globalkeysolutions.net/companies/datong-tongxing-antibiotics-co-ltd/43ef8a80-fb6c-4e5a-ad04-3b34fb6e138e

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8