康泰医学(300869.SZ)：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] Financial Impact - In 2024, the company achieved sales revenue of 114.4003 million yuan from the U.S., accounting for 23.84% of total revenue for the same period [1] - In the first half of 2025, the company generated sales revenue of 41.8903 million yuan from the U.S., representing 19.26% of total revenue for that period [1] Regulatory Compliance - The FDA's warning letter indicates that the company's medical device products exported to the U.S. did not meet the requirements of the U.S. Federal Regulations 21 CFR Part 820 [1] - The FDA will take measures to refuse the company's products from entering the U.S. market until the identified violations are resolved [1]