# FDA 483 - Hebei Jingye Medical Technology Corp., LTD. - June 28, 2024

Source: https://www.globalkeysolutions.net/records/483/hebei-jingye-medical-technology-corp-ltd/75cf82ba-77d2-4575-afa0-48c6f2833a32

> FDA 483 for Hebei Jingye Medical Technology Corp., LTD. on June 28, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hebei Jingye Medical Technology Corp., LTD.
- Inspection Date: 2024-06-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hebei Jingye Medical Technology Co., Ltd. in Cangzhou, China, an API manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included failures in change control management, supplier qualification, equipment maintenance, and timely record-keeping. These issues indicate a lack of adherence to established procedures and a potential impact on API quality.

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- [Mathematical statistician](https://www.globalkeysolutions.net/people/wen-ning-chan/e1f71810-6994-4474-876f-699ea9dee32c)

Company: https://www.globalkeysolutions.net/companies/hebei-jingye-medical-technology-corp-ltd/d33bd628-036d-4566-b6f7-5e017b28a03f

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