CONTEC: The FDA issued a warning letter to the company
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
According to the Zhitong Finance APP, CONTEC (300869.SZ) announced that on October 2, 2025, it received a warning letter from the U.S. Food and Drug Administration (FDA). This warning letter was based on the results of an on-site inspection conducted by the FDA at the company's facility in Qinhuangdao, Hebei Province, from June 9 to June 12, 2025. The letter raised concerns regarding the company's medical device products exported to the U.S. market, indicating non-compliance with the requirements of the U.S. federal regulations 21 CFR Part 820 Quality System Regulation (QS regulation) in areas such as production, packaging, storage, or installation, and provided relevant inspection opinions and improvement requirements. Until these violations are resolved, the FDA is taking measures to refuse the company's products entry into the U.S.
In 2024, the company achieved sales revenue of 114.4003 million yuan in the U.S., accounting for 23.84% of the company's total revenue during the same period; in the first half of 2025, the sales revenue in the U.S. was 41.8903 million yuan, accounting for 19.26% of the company's total revenue during the same period. Therefore, this matter may have a certain impact on the company's normal business activities in the U.S. market in the future
