Paulette (300246.SZ) issued an announcement. The company recently received the holding subsidiary Mihara Fusheng Medical Devices Co., Ltd...
Zhitong Finance App News, Paulette (300246.SZ) issued an announcement. The company recently received a notice from its holding subsidiary Mihara Fusheng Medical Devices Co., Ltd. (“Mihara Fusheng”). The China Drug Administration recently carried out a flight inspection on Mihara Fusheng, and published the “Notice of the State Drug Administration on the flight inspection situation of two companies including Heilongjiang Xinxipin Medical Technology Co., Ltd.” (No. 20 of 2024) on the website of the State Drug Administration.
The “Notice” indicates that Fusheng Mihara has serious flaws in the company's quality management system in terms of institutional personnel, plant and facilities, production management, and quality control, and does not comply with the relevant provisions of the “Medical Device Production Quality Management Code”. Tomio Mihara has confirmed that the above quality management system is flawed. The “Notice” requires the relevant territorial provincial drug supervision and administration departments to take control measures to order the suspension of production in accordance with the provisions of Article 72 of the “Medical Device Supervision and Administration Regulations”; to deal with suspected violations of the “Medical Device Supervision and Administration Regulations” and related regulations in accordance with the law; and to order enterprises to assess product safety risks and recall related products in accordance with the provisions of the “Medical Device Recalls Management Measures”.
The day after this flight inspection, Mihara Fusheng took the initiative to apply to the Shaanxi Drug Administration for discontinuation of production and rectification in view of the actual situation. At the same time, the Shaanxi Drug Administration commissioned the Shaanxi Drug Safety Sampling Technology Center to sample the inventory products, carried out full project inspection by the Shaanxi Medical Device Quality Inspection Institute, and issued an inspection conclusion: “The items tested on the tested samples met the requirements of Guoyi Equipment Note 20193100742 “Technical Requirements for Hemodialysis Concentrate Products”. Under the supervision and guidance of the Shaanxi Drug Administration, Mihara Fusheng carried out comprehensive and thorough rectification of the non-compliance with this flight inspection.
At present, Mihara Fusheng has completed the rectification. It will submit a “Rectification Report” to the Shaanxi Drug Administration on May 30, 2024, and apply for a resumption of production inspection.