康泰医学(300869.SZ)：FDA向公司出具警告信，FDA正在采取措施拒绝公司产品进入美国

Core Viewpoint - 康泰医学 received a warning letter from the FDA on October 2, 2025, due to non-compliance with medical device quality system regulations during an inspection conducted from June 9 to June 12, 2025 [1] Company Summary - The warning letter cites issues related to the production, packaging, storage, or installation of medical devices exported to the U.S. market, which do not meet the requirements of the U.S. Federal Regulations 21CFRPart820 [1] - The company plans to submit a response report to the FDA within the specified timeframe, detailing corrective actions and timelines, while maintaining active communication with the FDA to resolve the issues [1] - In 2024, the company achieved sales revenue of 114.40 million yuan from the U.S., accounting for 23.84% of total revenue; in the first half of 2025, sales revenue from the U.S. was 41.89 million yuan, representing 19.26% of total revenue [1] - The warning may impact the company's normal operations in the U.S. market moving forward [1]