ECA新闻：投诉和召回处理缺陷导致警告信

翻译 ：JULIA  来源： Julia法规翻译04.10.2017Deficiencies in Complaint and RecallHandling cause Warning Letter投诉和召回处理缺陷导致警告信Dueto deficiencies in the investigation of the scope and root causes ofreported complaints, the U.S. Food and Drug Administration (FDA) has issued awarning letter to an Indian drug manufacturer. The FDA inspection already tookplace in December of 2016. Because of the non-satisfactory reply in regards tothe inspection findings by the manufacturer, the FDA issued the warning letterin August 2017.由于对所报告的投诉调查范围和根本原因存在缺陷，FDA签发了警告信给一个印度药品生产商。FDA检查是在2016年12月。由于不满意生产商对检查中发现缺陷的回复，FDA于2017年8月签发了警告信。TheFDA inspectors noticed that investigations into process deviations and ………………………………