# FDA 483 - Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. - August 01, 2023

Source: https://www.keypedia.com/records/483/zhejiang-jinhua-conba-bio-pharm-co-ltd/198dd118-429d-4ce8-858c-c5315e01f69e

> FDA 483 for Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd. on August 01, 2023. 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: 2023-08-01
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zhejiang Jinhua Conba Bio-Pharm Co. Ltd. was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed issues with facility separation leading to cross-contamination risks, inadequate employee training for visual inspection, and insufficient laboratory controls including media testing. Additionally, the firm lacked established procedures to prevent microbiological contamination of sterile products.

## Related Documents

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- [483 - 2025-04-28](https://www.keypedia.com/records/483/zhejiang-jinhua-conba-bio-pharm-co-ltd/55da3d8f-0e92-4743-8b33-55236fd6d046)

## Related Officers

- [Investigator](https://www.keypedia.com/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)

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

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