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科济药业-B(02171.HK)：就FDA发现项提交整改报告

Keji Pharmaceutical-B (02171.HK): Submission of a rectification report on FDA findings

Gelonghui Finance ·  Apr 28 20:07

Gelonghui, April 29 | Keji Pharmaceutical-B (02171.HK) issued an announcement. The rectification report on the Corrective and Preventive Measures (CAPAs) plan has been submitted to the US Food and Drug Administration (FDA). This submission relates to findings in Form 483 issued by the FDA after an inspection of the clinical production site in Tulham, North Carolina in December 2023. The relevant work is progressing smoothly according to the schedule previously submitted. The company promises to work closely with the FDA to prioritize quality and ensure the production of clinical trial products.

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