China NMPA Inspection - Shandong Baiduoan Medical Equipment Co., Ltd. - October 11, 2016

A surprise inspection report, published on October 11, 2016, by the National Medical Products Administration (NMPA), detailed the findings concerning Shandong Aosaite Medical Device Co., Ltd. The inspection was prompted by the company's "Application Report on the Suspension and Renovation of the Negative Pressure Blood Collection Tube Workshop," submitted on September 1, 2016, to the Shandong Provincial, Heze Municipal, and Chengwu County Food and Drug Administrations. During the on-site verification in September 2016, the inspection team confirmed that Shandong Aosaite Medical Device Co., Ltd. was indeed in a state of suspended production. This suspension was specifically related to its Negative Pressure Blood Collection Tube Workshop, indicating a significant operational halt for renovation purposes. To ensure compliance and patient safety, the company is mandated to undertake specific actions before resuming manufacturing activities. Shandong Aosaite Medical Device Co., Ltd. is required to submit a comprehensive written report to the Shandong Provincial Food and Drug Administration. Crucially, production cannot recommence until the Shandong Provincial Food and Drug Administration has officially verified that all requirements are met and has granted explicit approval. This rigorous process is designed to ensure the company's facilities and processes adhere to established standards following renovation.