FDA 483 - Qingdao Kangyuan Pharmaceutical Co. Ltd. - April 18, 2026
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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.
ID · 7e405f58-7a2a-4be2-b8fc-b0300d51e054