Kangji Pharmaceutical-B submits a corrective action report to the FDA for the discovery item
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According to the news from Zhitong Finance and Economics APP, Keji Pharmaceutical-B has announced that the corrective and preventive action (CAPA) plan's rectification report has been submitted to the U.S. Food and Drug Administration (FDA). This submission is related to the findings in the 483 form issued by the FDA in December 2023 after inspecting the clinical production base in Terre Haute, North Carolina. The related work is progressing smoothly according to the previously submitted timeline. The company has committed to closely cooperate with the FDA, prioritize quality, and ensure the production of clinical trial products
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