# FDA 483 - Jiangsu Baozong & Baoda Pharmachem Co., Ltd. - March 28, 2025

Source: https://www.keypedia.com/records/483/jiangsu-baozong-baoda-pharmachem-co-ltd/4c1d173f-470c-4409-aa1d-51dc816988c8

> FDA 483 for Jiangsu Baozong & Baoda Pharmachem Co., Ltd. on March 28, 2025. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Baozong & Baoda Pharmachem Co., Ltd.
- Inspection Date: 2025-03-28
- Product Type: veterinary
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Jiangsu Baozong & Baoda Pharmachem Co., Ltd. in Nantong, China, revealed significant deficiencies in the manufacturing of Active Pharmaceutical Ingredients for Veterinary Use. Observations included inadequate control and documentation of production equipment, lack of proper cleaning and storage, and insufficient laboratory testing for API release and stability. These issues indicate a serious lack of quality control and good manufacturing practices.

## Related Documents

- [483 - 2019-06-21](https://www.keypedia.com/records/483/jiangsu-baozong-baoda-pharmachem-co-ltd/dd02645d-a2eb-472a-adc0-c5c8acf89e86)

## Related Officers

- [Sara H. Gabel](https://www.keypedia.com/people/sara-h-gabel/cd0cd510-ef95-4322-a766-503c994c1f64)

Company: https://www.keypedia.com/companies/jiangsu-baozong-baoda-pharmachem-co-ltd/b353c82d-34a4-40db-8541-3540be220c7d

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