康泰医学：FDA向公司出具警告信，未来可能会对公司在美国市场的正常经营活动产生一定影响

Core Viewpoint - The company 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 - The warning letter was issued based on findings from an FDA inspection of the company's facility in Qinhuangdao, Hebei Province [1] - The FDA identified issues related to the production, packaging, storage, or installation of medical devices intended for export to the U.S. market [1] - The FDA will refuse the company's products entry into the U.S. until the identified violations are resolved and the warning letter is closed [1]