Ningxia Hengkang Technology Co., Ltd.March 14, 2025

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

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Record Details

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.

Company: Ningxia Hengkang Technology Co., Ltd.
Inspection Date: March 14, 2025
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Nicholas L. Hunt (Senior CSO, Investigator)

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ID · a933d2e7-d312-4aae-b953-dc487c2d7e8e