300869，收到FDA警告信

Group 1 - The core issue is that 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 [2] - The warning letter indicates that 康泰医学's medical devices exported to the U.S. did not meet the requirements of the U.S. federal regulations 21 CFR Part 820, which may lead to the rejection of its products until the issues are resolved [2] - 康泰医学 plans to submit a response report to the FDA detailing corrective actions and timelines, aiming to resolve the issues and lift the warning [2] Group 2 - In 2024, 康泰医学 generated sales revenue of 114 million yuan from the U.S., accounting for 23.84% of its total revenue, while in the first half of 2025, sales revenue from the U.S. was 41.89 million yuan, representing 19.26% of total revenue [2] - The company has a high export ratio, with 73.08% of its sales coming from international markets in 2024, indicating potential broader impacts from the FDA's judgment on sales in other countries [3] - As of September 16, 2025, the second-largest shareholder, 王桂丽, reduced her stake in 康泰医学 to 10% from 14.7% since 2021, indicating a significant decrease in ownership [3] Group 3 - On October 10, 康泰医学's stock closed at 16.4 yuan per share, with a market capitalization of 6.59 billion yuan [4]