China NMPA Inspection - Hebei Ziweishan Pharmaceutical Co., Ltd. - October 30, 2017

Hebei Ziweishan Pharmaceutical Co., Ltd. underwent an unannounced compliance inspection from September 28-29, 2017, concerning its Hemodialysis Concentrate product. Conducted under the Good Manufacturing Practice for Medical Devices framework, the inspection identified several critical deficiencies. Key violations included inadequate storage conditions for sodium chloride raw material, which lacked essential humidity control and cooling facilities. Significant corrosion was noted on screws within the Agent A preparation room, both on the floor and the stainless steel platform of the preparation tank, indicating a lack of established anti-corrosion protection regulations. Documentation control issues were also apparent, with an undocumented revision of a cleaning procedure and failure to properly manage an obsolete document. Furthermore, the company failed to adhere to its "Sample Retention Management System," as no records of sample retention or observation were found. An inaccuracy on a finished product release form for batch 170905L was also noted. As a result, the Hebei Provincial Food and Drug Administration has mandated that Hebei Ziweishan Pharmaceutical rectify all issues promptly, conduct a product safety risk assessment, and recall any potentially unsafe products. Follow-up inspections are required, with a report to the State Administration for Market Regulation upon rectification.