China NMPA Inspection - Zhengzhou Zhangguang 101 Hair Growth Technology Co., Ltd. - December 05, 2017

An unannounced regulatory inspection was conducted on October 29, 2017, at Zhengzhou Zhangguang 101 Hair Growth Technology Co., Ltd. This inspection, likely part of a National Medical Products Administration (NMPA) oversight, identified multiple significant non-compliance issues within the company's production and quality control systems.Key violations included the insufficient implementation of the "Cleanroom Supervision and Inspection Management System," evidenced by the absence of status indicators on some operating room equipment. Furthermore, the company lacked proper documentation for certain raw materials, specifically purchase invoices and factory inspection reports, despite their reported qualified status. Production record deficiencies were also noted, such as missing origin and batch numbers for raw medicinal materials in batch records, unsigned data changes during filling and packaging, and the omission of material balance calculations for packaging materials. Lastly, several instruments were found without valid calibration certificates or status indicators, and their original inspection records were incomplete.As a result, Zhengzhou Zhangguang 101 Hair Growth Technology Co., Ltd. was formally directed to implement immediate corrective measures. The case has since been referred to the Zhengzhou Municipal Bureau for further investigation and appropriate legal proceedings.