China NMPA Drug Inspection - Wujing Community Health Service Center, Minhang District, Shanghai - Polygala tenuifolia (processed Polygala tenuifolia)

The Shanghai Municipal Food and Drug Administration released its 2018 Issue 5 Drug Supervision and Sampling Quality Announcement on June 11, 2018, detailing findings from comprehensive inspections of drug and pharmaceutical packaging material units across production, operation, and use stages. These inspections covered products with batch numbers primarily ranging from 2016 to 2018.

Numerous pharmaceutical companies were cited for non-compliant products, predominantly traditional Chinese medicine slices. Significant violations included issues with product appearance, improper processing, and deviations from moisture content standards. More critical findings involved contamination with heavy metals such as mercury, the presence of aflatoxin (a known carcinogen), and the unauthorized detection of auramine O. Additional non-compliances related to content determination, product properties, insect infestation, and ash content.

These regulatory checks were based on established frameworks, including the 2015 Edition Chinese Pharmacopoeia and the 2008 Edition Shanghai Processing Regulations. As a result, the Shanghai Municipal Food and Drug Administration mandated immediate suspension of sales and use for unqualified products, comprehensive product recalls, and prompt rectification of all identified issues. Furthermore, the administration committed to intensified follow-up inspections and instructed local market supervision bureaus to enhance daily oversight, ensuring companies investigate root causes and implement corrective measures to prevent future quality risks.