China NMPA Inspection - Shanghai Kaichuang Biotechnology Co., Ltd. - May 27, 2016

An unannounced inspection of Shanghai Kaichuang Biotechnology Co., Ltd. was conducted, with the official report published by the National Medical Products Administration (NMPA) on May 27, 2016. The inspection revealed that the company's operations did not comply with the essential requirements of the Good Manufacturing Practice for Medical Devices, which is the key regulatory framework governing medical product quality and safety. Significant deficiencies were identified within the company's quality management system, indicating a failure to maintain robust internal controls and processes. Specifically, the observed actions and practices of Shanghai Kaichuang Biotechnology Co., Ltd. were found to be inconsistent with established manufacturing standards for medical devices. As a direct consequence of these findings, the Shanghai Municipal Food and Drug Administration has issued a directive. The company is formally ordered to address and rectify all identified deficiencies within a specified period, ensuring its operations are brought into full compliance with national medical device regulations. This regulatory action emphasizes the importance of strict adherence to quality standards to protect public health.