# FDA 483 - North China Pharmaceutical Huasheng Co., LTD - August 10, 2018

Source: https://www.globalkeysolutions.net/records/483/north-china-pharmaceutical-huasheng-co-ltd/7d264857-93e9-4bf6-9c9e-bc7f34df904c

> FDA 483 for North China Pharmaceutical Huasheng Co., LTD on August 10, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North China Pharmaceutical Huasheng Co., LTD
- Inspection Date: 2018-08-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of North China Pharmaceutical Huasheng Co., Ltd., an Active Pharmaceutical Ingredients manufacturer, revealed significant deficiencies across multiple areas. The firm failed to adequately validate critical manufacturing processes, ensure the suitability of water used in API production, and maintain proper cleaning and storage of equipment and utensils. These issues indicate a lack of robust quality control and could compromise product quality.

## Related Officers

- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.globalkeysolutions.net/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)

Company: https://www.globalkeysolutions.net/companies/north-china-pharmaceutical-huasheng-co-ltd/3ab06436-8d2e-4638-95a2-e80b11066d81

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1