Wuhan BBT Minimally Invasive Medical Technology Failed FDA Inspection and Was Ordered to Halt Production for Rectification
MicroPort
High-end Medical Device R&D and Manufacturer
China.com.cn Finance, September 18 (Reporter Niu He): Today, the National Medical Products Administration released the Announcement on the Unannounced Inspection of Wuhan Banbiantian Minimally Invasive Medical Technology Co., Ltd. (No. 63 of 2020).
Notice stated that during an unannounced inspection of Wuhan Banbiantian MicroPort Medical Technology Co., Ltd. organized by the National Medical Products Administration (NMPA), deficiencies were identified in the company’s quality management system, primarily in the areas of design and development and control of nonconforming products, which failed to comply with the relevant provisions of the Good Manufacturing Practice for Medical Devices. The company has confirmed the aforementioned deficiencies in its quality management system.
Among these, in terms of nonconforming product control, the corrective actions actually taken for nonconformities were inconsistent with the review records, which does not comply with the requirements of the Good Manufacturing Practice for Medical Devices that nonconforming products shall be identified, recorded, isolated, and reviewed, and corresponding disposition measures shall be taken based on the review results.
The National Medical Products Administration has instructed the Hubei Provincial Medical Products Administration to order the enterprise to immediately suspend production and implement corrective measures in accordance with the law, and to impose strict penalties for any violations of the Regulations on the Supervision and Administration of Medical Devices and other relevant laws and regulations. The National Medical Products Administration has also directed the Hubei Provincial Medical Products Administration to require the enterprise to assess product safety risks and, where potential safety hazards are identified, to recall the relevant products in accordance with the provisions of the Measures for the Administration of Medical Device Recalls.
The National Medical Products Administration stated that the enterprise may resume production only after completing all rectification items and passing the re-inspection conducted by the Hubei Provincial Medical Products Administration. The Hubei Provincial Medical Products Administration shall promptly report the enterprise’s rectification status to the National Medical Products Administration.
According to available records, Wuhan Banbiantian MicroPort Medical Technology Co., Ltd. was established in November 2014, with a registered capital of RMB 10 million and an actual paid-in capital of only RMB 500,000. Wuhan Banbiantian Medical Technology Development Co., Ltd. is its wholly-owned controlling shareholder, holding 100% of the shares. Qiu Xuewen serves as the legal representative, executive director, and general manager.
Meanwhile, Qiu Xuewen is the majority shareholder of Wuhan Banbiantian Medical Technology Development Co., Ltd., holding a 60% equity stake, while Qiu Kexin is the second-largest shareholder, holding a 40% equity stake.
Notably, in July this year, Wuhan Banbiantian MicroPort Medical Technology Co., Ltd. was publicly notified for having substandard products.
On July 27, 2020, the National Medical Products Administration released the “Announcement on the Release of National Supervisory Spot Check Results for Medical Devices (No. 3) (2020 No. 52),” which indicated that the “High-Frequency Surgical Equipment” (Model BBT-RFS-C280) manufactured by Wuhan Banbiantian Minimally Invasive Medical Technology Co., Ltd. failed to comply with specified standards. The non-compliant items were “thermal effects of high-frequency leakage current” and “accuracy of control devices and instruments.”
