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April 10, 2024 Philips confirms that further to communicating the main terms of the Philips Respironics consent decree on January 29, 2024, Philips’ subsidiaries Philips Holding USA and Philips Respironics have now reached final agreement on the consent decree with the DOJ and FDA. As previously stated: The consent decree primarily focuses on Philips Respironics’ business operations in the US.It provides clarity and a roadmap to demonstrate compliance with regulatory requirements and to restore the Philips Respironics business.
2024年4月10日飞利浦确认,继2024年1月29日传达飞利浦呼吸系统同意令的主要条款后,飞利浦的子公司飞利浦控股美国公司和飞利浦呼吸系统公司现已与司法部和FDA就同意令达成最终协议。如前所述:同意令主要关注飞利浦Respironics在美国的业务运营。它提供了清晰的说明和路线图,以证明符合监管要求并恢复飞利浦Respironics的业务。
Philips Respironics is committed to meeting the consent decree requirements, while continuing to service healthcare providers and their patients under agreed conditions in the US and outside the US. The 2023 – 2025 Group financial outlook takes the consent decree into account and remains unchanged. Amsterdam, the Netherlands - Following the FDA’s inspection of Philips Respironics’ facility in Murrysville in 2021 and the subsequent inspectional observations, the US Department of Justice (DOJ), representing the US Food and Drug Administration (FDA), began discussions with Royal Philips (NYSE: PHG, AEX: PHIA) in July 2022 regarding the terms of a proposed consent decree.
飞利浦呼吸系统致力于满足同意令的要求,同时继续在美国国内外按照商定的条件为医疗保健提供者及其患者提供服务。2023-2025年集团财务展望考虑了同意令,并保持不变。荷兰阿姆斯特丹——2021年,美国食品和药物管理局(FDA)对飞利浦呼吸系统公司(Philips Respironics)在默里斯维尔的工厂进行了检查,随后进行了检查观察,代表美国食品和药物管理局(FDA)的美国司法部(DOJ)于2022年7月开始与皇家飞利浦(纽约证券交易所:PHG,AEX:PHIA)就拟议同意令的条款进行讨论。
On January 29, 2024, Philips announced that it agreed with the DOJ and FDA on the terms of the proposed consent decree. Philips’ subsidiaries Philips Holding USA and Philips Respironics have now reached final agreement on the consent decree with the DOJ and FDA, that primarily focuses on Philips Respironics’ business operations in the US, including its manufacturing facilities in Murrysville and New Kensington, its service center in Mount Pleasant and its Respironics headquarters in Pittsburgh in Pennsylvania.
2024年1月29日,飞利浦宣布,它与司法部和FDA就拟议同意令的条款达成一致。飞利浦的子公司飞利浦控股美国公司(Philips Holding USA)和飞利浦Respironics公司(Philips Respironics)现已与美国司法部和美国食品和药物管理局(FDA)就许可令达成最终协议,该许可令主要关注飞利浦Respironics公司在美国的业务运营,包括其在默里斯维尔(Murrysville)和新肯辛顿(New Kensington)的制造工厂、其在普莱森特山(Mount Pleasant)的服务中心以及其在。
The consent decree provides Philips Respironics with a roadmap of define.
同意令为飞利浦Respironics提供了定义的路线图。