# FDA 483 - Hubei JXBio Pharmaceutical Co., Ltd - August 30, 2024

Source: https://www.keypedia.com/records/483/hubei-jxbio-pharmaceutical-co-ltd/9eff666e-9662-4a10-aa64-6820f3666c60

> FDA 483 for Hubei JXBio Pharmaceutical Co., Ltd on August 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hubei JXBio Pharmaceutical Co., Ltd
- Inspection Date: 2024-08-30
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hubei JX Bio Pharmaceutical Co., Ltd. in Xianning, China, revealed significant deficiencies across quality, facility, and production operations. The firm was cited for inadequate personnel training and record-keeping, poorly established equipment cleaning procedures, and failure to assure in-process materials conform to specifications through proper testing. These observations highlight critical gaps in the company's quality management system.

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## Related Officers

- [Saed Asbyl](https://www.keypedia.com/people/saed-asbyl/c0a03e9f-7dc5-4ca0-84f7-5cd1630fd616)

Company: https://www.keypedia.com/companies/hubei-jxbio-pharmaceutical-co-ltd/0cb70a5f-908f-45e1-bf50-87d4e83281b5

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