China NMPA Inspection - Jiangsu Jiasikang Technology Co., Ltd. - May 27, 2016

An unannounced inspection conducted by the Jiangsu Provincial Food and Drug Administration revealed significant compliance issues at Jiangsu Jiasikang Technology Co., Ltd. The inspection report, published on May 27, 2016, identified that the company's operational practices did not adhere to the stringent requirements of the Good Manufacturing Practice for Medical Devices. Specifically, the inspection highlighted critical deficiencies within the company's quality management system, indicating a failure to maintain the necessary standards for medical device production. As a direct consequence of these findings, Jiangsu Jiasikang Technology Co., Ltd. has been mandated to immediately halt all production activities. Furthermore, the company is required to undertake comprehensive rectification measures to address the identified non-compliances and restore its quality management system to full regulatory compliance. This decisive action, communicated by the National Medical Products Administration (NMPA), underscores the regulatory body's commitment to ensuring the safety and quality of medical devices within its jurisdiction, holding manufacturers accountable to established industry standards.