# FDA 483 - Zhejiang Jinhua Conba Bio-pharm. Co., Ltd. (Jinxi) - January 10, 2025

Source: https://www.globalkeysolutions.net/records/483/zhejiang-jinhua-conba-bio-pharm-co-ltd-jinxi/2737ddfd-182b-4bef-9768-35f6c6f1c503

> FDA 483 for Zhejiang Jinhua Conba Bio-pharm. Co., Ltd. (Jinxi) on January 10, 2025. 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. (Jinxi)
- Inspection Date: 2025-01-10
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zhejiang Jinhua Conba Bio-pharm, Co., Ltd., an API manufacturer in Jinhua City, China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate validation of analytical methods for drug substances, insufficient controls over computerized systems leading to potential data manipulation, and failure to ensure equipment cleanliness before use, with residue found after cleaning. These issues indicate a lack of robust quality control and data integrity practices.

## Related Officers

- [Supervisory Consumer Safety Officer, China Office](https://www.globalkeysolutions.net/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

Company: https://www.globalkeysolutions.net/companies/zhejiang-jinhua-conba-bio-pharm-co-ltd-jinxi/c177bf6b-63d3-441c-9748-c42b7e970bdd

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8