# FDA 483 - Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. - January 22, 2018

Source: https://www.keypedia.com/records/483/zhejiang-jinhua-conba-bio-pharm-co-ltd/1f800525-7e82-4e4b-bc60-4c96381440f8

> FDA 483 for Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. on January 22, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.
- Inspection Date: 2018-01-22
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd., an API manufacturer, revealed significant deficiencies in their quality systems. The firm was cited for incomplete investigations into out-of-specification results and equipment failures, as well as inadequate laboratory controls lacking scientifically sound procedures. Furthermore, the inspection identified insufficient validation of cleaning, manufacturing, and sealing processes, alongside ineffective equipment cleaning and maintenance practices.

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## Related Officers

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

Company: https://www.keypedia.com/companies/zhejiang-jinhua-conba-bio-pharm-co-ltd/ccf6fb2b-5de1-4f70-903b-d442374003f6

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