China NMPA Drug Inspection - Shanghai Duzhuang Clinic - Gentiana macrophylla

The Shanghai Municipal Food and Drug Administration (SMFDA) issued its 2018 Issue 9 Drug Supervision and Sampling Quality Announcement on October 16, 2018, following quality supervision and sampling inspections across drug production, operation, and use units. The initiative aimed to enhance quality oversight, regulate the market, and ensure the safety of pharmaceutical products. Multiple companies, including Hebei Quantai Pharmaceutical, Shaohuatang Traditional Chinese Medicine, Anhui Yi Yishengtang Chinese Herbal Pieces, Tianma (Anhui) National Pharmaceutical Technology, Shanghai Huaying Pharmaceutical, and Shanghai Pharmacy Co., Ltd., were identified as manufacturers of non-compliant products.

Thirteen drug products, primarily Chinese medicinal slices such as Paeonia lactiflora, Eucommia ulmoides, and Belamcanda chinensis, failed inspections. The main violations, assessed against the 2015 Edition Chinese Pharmacopoeia, included deficiencies in "Appearance," "Processing," "Content Determination," "Properties," and "Moisture" content. These issues indicate concerns with the physical characteristics, preparation methods, active ingredient levels, and storage stability of the drugs.

As a result, the SMFDA mandated immediate control measures. Non-compliant units were required to suspend sales, cease product use, recall affected batches, and undertake risk-based rectification. The administration also committed to intensified follow-up inspections and random checks. Local market supervision bureaus were directed to strengthen daily oversight, ensure companies investigate root causes, and implement corrective actions to mitigate potential risks and ensure ongoing compliance.