康泰医学收FDA警告信

Core Points - 康泰医学 received a warning letter from the FDA on October 2, based on an inspection conducted from June 9 to 12, indicating non-compliance with the quality system regulations for medical devices [1] - The FDA's warning letter highlights issues related to the production, packaging, storage, or installation of medical devices intended for the U.S. market, which could lead to the rejection of the company's products until the violations are resolved [1] - The company plans to respond to the FDA within the specified timeframe, detailing corrective actions and timelines to address the issues raised [1] Financial Impact - In 2024, 康泰医学 expects to generate sales revenue of 114.4 million yuan from the U.S., accounting for 23.84% of the company's total revenue for that period [1] - For the first half of 2025, the projected sales revenue from the U.S. is 41.89 million yuan, representing 19.26% of the company's total revenue for that period [1] - The warning letter may have a significant impact on the company's normal business operations in the U.S. market moving forward [1]