康泰医学：FDA向公司出具警告信

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] Group 1: FDA Warning and Compliance - The warning letter was issued based on findings from an FDA inspection that identified issues related to the production, packaging, storage, or installation of medical devices exported to the U.S. market [1] - The FDA has indicated that it will refuse the company's products entry into the U.S. until the identified violations are resolved [1] - The company is committed to addressing the FDA's concerns and will submit a response report detailing corrective actions and timelines within the specified period [1] Group 2: Financial Impact - In 2024, the company achieved sales revenue of 114 million yuan from the U.S., accounting for 23.84% of its total revenue during that period [1] - In the first half of 2025, the company generated sales revenue of 41.89 million yuan from the U.S., representing 19.26% of its total revenue for that period [1] - The ongoing FDA issues may significantly impact the company's normal business operations in the U.S. market moving forward [1]