China NMPA Drug Inspection - Jiangsu Lianshui Pharmaceutical Co., Ltd. - Paris polyphylla

The Sichuan Provincial Drug Administration announced the findings from its 2019 Drug Sampling Inspection Work Plan on December 3, 2019. The inspections, conducted across drug production, distribution, and use units in various cities and prefectures, identified 29 batches of products from multiple manufacturers failing to meet established quality standards.

Violations encompassed a range of quality control parameters. These included discrepancies in tablet or pack weight, issues with product appearance, and deviations in content determination for active ingredients. Specific non-compliances also related to product properties and identification, such as issues with free salicylic acid, rhein content, total ash, water content, and improper identification via microscopic or thin-layer chromatography methods.

These inspections were carried out in accordance with a robust regulatory framework, primarily referencing the "Chinese Pharmacopoeia" (various editions), "National Drug Standards," "Ministry of Health Drug Standards," and the "Sichuan Province Traditional Chinese Medicine Decoction Pieces Processing Specification."

In response to these findings, the regulatory authorities have mandated that the implicated enterprises take immediate actions. These include suspending the sale and use of the affected products, initiating recalls, thoroughly investigating the root causes of the non-compliance, and implementing comprehensive rectification measures to ensure future adherence to quality standards.