FDA警告Philips 注意美国制造的缺陷 影响装置安全 FDA warns Philips over U.S. manufacturing flaws affecting device safety.

美国食品和药物管理局向飞利浦发出警告信,指出其在美国的Bothell,Reedsville和Nederland的工厂存在制造缺陷,并指出这些工厂未能达到当前的良好制造实践标准. The FDA issued a warning letter to Philips over manufacturing deficiencies at its U.S. facilities in Bothell, Reedsville, and Nederland, citing failures to meet current Good Manufacturing Practice standards. 该机构发现了质量控制、投诉处理和错误解决方面的问题,引起对装置安全和可靠性的关切。 The agency found issues in quality control, complaint handling, and error resolution, raising concerns about device safety and reliability. 虽然没有宣布任何回顾,但违反行为可能导致执法行动。 While no recalls have been announced, the violations could lead to enforcement actions. 飞利浦必须提交一个纠正计划,建议患者和医疗服务提供者监控FDA的最新情况. Philips must submit a corrective plan, and patients and providers are advised to monitor FDA updates.