# FDA 483 - Chifeng Pharmaceutical Company, Ltd. - January 19, 2024

Source: https://www.globalkeysolutions.net/records/483/chifeng-pharmaceutical-company-ltd/94a1e428-ecd8-4f35-ac5d-4ea87b3ea29f

> FDA 483 for Chifeng Pharmaceutical Company, Ltd. on January 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chifeng Pharmaceutical Company, Ltd.
- Inspection Date: 2024-01-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Chifeng Pharmaceutical Co, Ltd's Active Pharmaceutical Ingredient manufacturing facility in Chifeng, China, revealed significant deficiencies in quality control and facility maintenance. Observations included unvalidated test methods, an inadequate cleaning validation program, unqualified equipment, and poor building and equipment upkeep. These findings indicate a lack of adherence to good manufacturing practices.

## Related Documents

- [483 - 2017-10-13](https://www.globalkeysolutions.net/records/483/chifeng-pharmaceutical-company-ltd/deee763a-484f-4fbf-b5b0-fddb433b6a3d)

## Related Officers

- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.globalkeysolutions.net/companies/chifeng-pharmaceutical-company-ltd/3b71193c-338c-4461-ba6b-51e9f1b9711a

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