# FDA 483 - Chifeng Pharmaceutical Company, Ltd. - October 13, 2017

Source: https://www.globalkeysolutions.net/records/483/chifeng-pharmaceutical-company-ltd/deee763a-484f-4fbf-b5b0-fddb433b6a3d

> FDA 483 for Chifeng Pharmaceutical Company, Ltd. on October 13, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chifeng Pharmaceutical Company, Ltd.
- Inspection Date: 2017-10-13
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Chifeng Pharmaceutical Co., Ltd. in Chifeng, P.R. China, an Active Pharmaceutical Ingredient Manufacturer, received a Form 483 with nine observations. The inspection revealed significant issues across contamination control, material management, deviation documentation, equipment qualification, record-keeping, quality reviews, software validation, and pest control. These findings indicate a broad lack of adherence to good manufacturing practices, posing potential risks to product quality and integrity.

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## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.globalkeysolutions.net/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321