China NMPA Drug Inspection - Shanghai STA Pharmaceutical Product Co., Ltd. - Polygala tenuifolia (processed Polygala tenuifolia)

The Shanghai Municipal Food and Drug Administration (Shanghai FDA) released its 2018 Issue 5 Drug Supervision and Sampling Quality Announcement on June 11, 2018. This announcement detailed findings from quality supervision inspections of drug and pharmaceutical packaging materials conducted across production, operation, and use units in Shanghai. The initiative aimed to strengthen quality oversight, regulate market order, and ensure the safety of marketed drugs.

Numerous companies, including manufacturers such as Tongling Hetian Traditional Chinese Medicine Slices Co., Ltd., Shanghai Hongqiao Traditional Chinese Medicine Slices Co., Ltd., and various pharmacies and hospitals, were identified for non-compliance. Common violations included deficiencies in product appearance, improper processing, excessive moisture content, presence of heavy metals (e.g., mercury), detection of harmful substances like aflatoxin and auramine O, and inaccurate content determination. These issues were assessed against established standards, primarily the 2015 Edition Chinese Pharmacopoeia and the 2008 Edition Shanghai Processing Regulations.

In response to these findings, the Shanghai FDA mandated immediate actions for non-compliant units, requiring them to suspend sales, recall affected products, and implement thorough rectification measures. The administration also committed to strengthening follow-up and random inspections. Local market supervision bureaus are tasked with enhanced daily oversight, urging enterprises to investigate root causes, formulate and execute corrective actions, and mitigate future risks to safeguard public health and safety.