# FDA 483 - Zhejiang Charioteer Pharmaceutical Co. Ltd. - January 15, 2018

Source: https://www.globalkeysolutions.net/records/483/zhejiang-charioteer-pharmaceutical-co-ltd/9ef5292b-a649-472c-b8fa-e30916920715

> FDA 483 for Zhejiang Charioteer Pharmaceutical Co. Ltd. on January 15, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Charioteer Pharmaceutical Co. Ltd.
- Inspection Date: 2018-01-15
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Zhejiang Charioteer Pharmaceutical Co., Ltd., an API manufacturer in Zhejiang Province, China, revealed significant deficiencies in quality control. The firm failed to conduct complete investigations into out-of-specification results and customer complaints. Additionally, process parameters for cleaning and water manufacturing validation were not fully established or adequately controlled.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/zhejiang-charioteer-pharmaceutical-co-ltd/1b311d6e-f732-4126-b220-37035ec0877b

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd