China NMPA Inspection - Jilin Yizheng Pharmaceutical Group Co., Ltd. - February 06, 2018

Jilin Yizheng Pharmaceutical Group Co., Ltd. underwent an unannounced inspection by the State Food and Drug Administration and Siping Municipal Food and Drug Administration from November 1st to November 3rd, 2017. The inspection, prompted by drug sampling, focused on the production of Nüjin Pills and the use of specific pigments. Significant deficiencies were identified, primarily revolving around supplier and material management. The company exhibited disorganized auditing practices for Chinese medicinal herb suppliers, marked by incomplete documentation, a lack of tiered management, evidence of file alterations, and insufficient quality reviews. Material management was also found to be inadequate, as licorice and motherwort batches used in production lacked essential production batch numbers. A critical finding was the presence of three synthetic pigments – amaranth, sunset yellow, and brilliant blue – in ten batches of Nüjin Pills, highlighting serious failures in production process and raw material control. These violations were deemed a severe breach of the "Good Manufacturing Practice for Pharmaceuticals" (2010 Revision). Consequently, the Jilin Provincial Food and Drug Administration was directed to revoke the company's relevant GMP certificates, initiate investigations into the illegal activities, and refer any potentially criminal cases to public security authorities. The findings were publicly announced on February 6, 2018.