China NMPA Inspection - Yangling Biomedical Technology Co., Ltd. - July 09, 2018

An inspection by China's State Food and Drug Administration, with findings finalized by July 9, 2018, revealed severe compliance deficiencies at Yangling Biomedical Technology Co., Ltd., specifically concerning their production of Jieyu Anshen Granules. The investigation identified a fundamentally ineffective quality management system. The company failed to maintain essential records, including those for change control, deviations, corrective actions, and self-inspections, dating back to 2015. Product quality reviews were either incomplete or nonexistent, and critical trend analyses were not conducted. A significant violation involved a substantial increase in production batch size without appropriate change control, risk assessment, or process validation. Moreover, waste extract was improperly used in production, and stability studies were not performed under correct conditions.

Data integrity was critically compromised by missing batch records, electronic analytical data, and unarchived auxiliary records. Instances of original data modification were discovered, and no proper management program or validation procedures existed for computerized systems. Supplier management was also inadequate, lacking qualified supplier directories, annual audits, and complete supplier documentation. These violations demonstrated a clear failure to adhere to the *Good Manufacturing Practice for Pharmaceuticals (2010 Revision)*. Consequently, the Shaanxi Provincial Food and Drug Administration was instructed to revoke the company's GMP certificates and initiate legal proceedings for these regulatory breaches.