483
Qingdao Kangyuan Pharmaceutical Co. Ltd.Qingdao Kangyuan Pharmaceutical Co. Ltd. – FDA 483, Apr 18, 2026
Record Details
An FDA inspection of Qingdao Kangyuan Pharmaceutical Co., Ltd. revealed significant deficiencies, many of which were repeat observations from a previous inspection. The firm failed to adequately characterize impurity profiles, qualify equipment, and maintain proper control over its HVAC and water systems. Additionally, issues were noted with scale calibration, equipment placement, and adherence to written procedures, indicating a lack of robust quality control in API manufacturing.
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