# FDA 483 - Ningxia Hengkang Technology Co., Ltd. - March 14, 2025

Source: https://www.globalkeysolutions.net/records/483/ningxia-hengkang-technology-co-ltd/a933d2e7-d312-4aae-b953-dc487c2d7e8e

> FDA 483 for Ningxia Hengkang Technology Co., Ltd. on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ningxia Hengkang Technology Co., Ltd.
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Ningxia Hengkang Technology Co., Ltd. in Yinchuan, China, revealed deficiencies in laboratory control procedures. Specifically, the firm failed to maintain complete records of raw data generated during testing, with an IT administrator having undocumented access to chromatography software activity logs. This indicates a significant concern regarding data integrity and the reliability of analytical results.

## Related Officers

- [Senior CSO, Investigator](https://www.globalkeysolutions.net/people/nicholas-l-hunt/2f10c080-c02e-4cc3-a8a0-0675b9c4cc6d)

Company: https://www.globalkeysolutions.net/companies/ningxia-hengkang-technology-co-ltd/40b4d8bf-07ef-42ee-b85c-a5165befb277

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