在美国食品药品监督管理局对这家日本医疗器械制造商的六家工厂进行检查后，向其发出警告信，导致该公司股价出现2025年4月以来的最大跌幅。
Corp. shares tumbled the most since April 2025 after the US Food and Drug Administration issued a warning letter to the Japanese medical device maker following inspections the agency previously conducted at six facilities.
周二，奥林巴斯在公告中称，在东京股市该股股价一度下跌17%。该警告信涉及2025年末检查过程中发现的质量管理体系及生产流程方面的问题。公司表示，此次警告不会影响正常生产，预计也不会对财务业绩造成负面影响。
The company’s stock slumped as much as 17% in Tokyo. The letter relates to quality management system and process observations made after inspections conducted in late 2025, Olympus said in a filing Tuesday. The warning will not disrupt production and its not expected to impact financial results, it said.
杰富瑞日本公司的分析师斯蒂芬·巴克与山北美弥比在一份报告中指出：“虽然收到警告信在预料之中，但仍令人失望。毕竟距离检查结束已近一年，投资者原本期望FDA能认可奥林巴斯采取的整改措施。这封新信函则进一步证实，奥林巴斯的质量问题具有系统性特征。”值得一提的是，这并非奥林巴斯首次因FDA相关举措而股价暴跌：2025年6月，FDA曾通知各医疗机构，奥林巴斯旗下日本工厂生产的部分医疗器械被列入进口警示名单，当时该公司股价也曾一度下跌12%。
“The letter is not entirely unexpected, but it disappoints” as investors had hoped the FDA had accepted Olympus’s corrective actions, given that nearly a year had passed since the inspections, Jefferies Japan Ltd. analysts Stephen Barker and Miyabi Yamakita wrote in a note. “The new letter confirms that Olympus’s quality issues are systemic.”This isn’t the first time Olympus’s shares have plunged following an FDA action. When the agency alerted health-care providers in June 2025 that certain medical devices manufactured in Japan by Olympus’s unit were subject to import alerts, the stock sank as much as 12%.