CONTEC: The FDA issued a warning letter to the company
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CONTEC received a warning letter from the FDA on October 2, 2025, due to its medical device products not complying with U.S. federal regulations in areas such as production. The FDA raised improvement requirements after conducting an on-site inspection of the company in June 2025, and will refuse the company's products entry into the U.S. market until the warning letter is resolved. In the first half of 2024 and 2025, the company's sales revenue from the U.S. accounted for 23.84% and 19.26% of its total operating revenue, respectively. This incident may impact the company's operations in the U.S
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