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据《华尔街日报》报道,疫情期间,有1300多家在美国注册销售防护装备和其他医药设备的中国医疗器械公司将CCTC Service Inc.列为其在美国的代理,而这个据称位于特拉华州的实体使用的其实是虚假地址和电话。根据美国法律规定,所有的外国医疗器械制造商都必须在美国有一个代理人,能提供真实有效的地址,并在工作时间有人值守。这样的代理人是美国食品和药物管理局与这些海外公司之间的联络点,以协调检查、召回或其他紧急需求。然而,这个CCTC提供的地址位于Del.Wilmington的一栋三居室砖房,该房的租户和房东称对CCTC或任何中国公司一无所知。根据企业记录数据库,美国也没有任何一家以这个名字命名的公司存在。这似乎揭露了FDA的紧急使用授权计划出现了监管漏洞,然而FDA拒绝对CCTC发表评论。联邦检察官上周对一家将CCTC作为其美国代理人的中国制造商提起了刑事诉讼。该检察官称该制造商将不合格的口罩伪装成N95呼吸器,向美国出口,有可能使美国的医疗专业人员受到病毒的威胁。FDA的调查员称,该制造商的代理人(CCTC)没有回复电子邮件,“有理由相信CCTC是一家虚构的公司”。调查人员还表示,使用这些虚假代理人的外国制造商往往是为了“规避监管监督”。
More than 1,300 Chinese medical-device companies that registered to sell protective gear and other equipment in the U.S. during the coronavirus pandemic listed as their American representative a purported Delaware entity that uses a false address and nonworking phone number, according to a Wall Street Journal analysis. All foreign manufacturers of medical devices are required to have a representative with a real address in the U.S. and somebody available during business hours. Such U.S. agents serve as a point of contact between the Food and Drug Administration and these overseas companies, to coordinate inspections, recalls or other urgent needs. CCTC’s purported address is a three-bedroom brick house in Wilmington, Del., whose tenants and landlord say they know nothing about CCTC or any Chinese companies. Federal prosecutors last week filed a criminal complaint against a Chinese manufacturer that listed CCTC as its U.S. agent, charging that the listing was part of false registration documents. The FDA investigator said in the complaint, filed in a Brooklyn, N.Y., federal court, that the agent didn’t respond to emails and there was “probable cause to believe CCTC is a fictitious corporation.” Foreign manufacturers who use fictitious U.S. agents, the investigator added, often do so “to circumvent regulatory oversight.” source
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