China NMPA Inspection - Yangzhou Xiaokang Medical Equipment Co., Ltd. - June 23, 2017

An unannounced inspection conducted by the State Food and Drug Administration (SFDA) on May 25, 2017, targeted Cangzhou Kang Le Medical Device Co., Ltd. The inspection was initiated under the "Regulations on Unannounced Inspections of Drugs and Medical Devices" and referenced "Good Manufacturing Practice for Medical Devices" along with its appendix for sterile medical devices. The primary finding was that Cangzhou Kang Le Medical Device Co., Ltd. had officially suspended all medical device production. The company had submitted production suspension reports to the Cangzhou Municipal Food and Drug Administration on April 21, 2016, and September 6, 2016. On-site verification confirmed that all production, including for the "Disposable Infusion Set with Needle," had ceased. No manufacturing violations were identified, as the company was inactive. To resume operations, Cangzhou Kang Le Medical Device Co., Ltd. is required to submit a written report to the Hebei Provincial Food and Drug Administration. Production can only recommence after the provincial administration verifies compliance with all relevant requirements. The provincial administration must also promptly inform the SFDA's Medical Device Supervision Department regarding the company's production resumption status.