康泰医学收FDA警告信 对美出口产品遭暂停

Core Viewpoint - 康泰医学 received a warning letter from the FDA due to non-compliance with medical device quality system regulations, which may impact its ability to operate in the U.S. market until the issues are resolved [1][2] Group 1: Company Impact - The U.S. market is crucial for 康泰医学, with projected sales revenue of 114 million yuan in 2024, accounting for 23.84% of total revenue, and 41.89 million yuan in the first half of 2025, representing 19.26% [2] - The warning letter indicates that 康泰医学's products will not receive market approval in the U.S. until the identified issues are addressed, potentially leading to long-term business stagnation if corrective actions are not timely and effective [2][3] Group 2: Regulatory Compliance - The FDA's inspection revealed issues related to the 21CFR Part 820 quality system regulation, which encompasses all aspects of the product lifecycle, including design, production, and post-market services [3] - Common deficiencies noted in similar cases include inadequate design controls, poor supplier audits, and ineffective corrective and preventive action (CAPA) systems [3] Group 3: Response Strategy - Experts suggest a three-step strategy for 康泰医学: 1. Sincere Response: Submit a detailed corrective action plan within 15 working days, addressing root causes and outlining specific corrective measures and timelines [4] 2. Solid Rectification: Acknowledge that rectification may take from several months to years, requiring significant resources and potentially leading to ongoing pressure on short-term performance [4] 3. Rebuild Trust: Even after resolving the warning, the FDA's scrutiny will likely remain high, and restoring confidence among U.S. customers and partners may take additional time [4]