China NMPA Drug Inspection - Shanghai Laiting Clinic - Bupleurum

The Shanghai Municipal Food and Drug Administration (SMFDA) released its 2018 Issue 2 Drug Supervision and Sampling Quality Announcement on March 13, 2018. This announcement detailed the findings from quality supervision and sampling inspections conducted on various drug and pharmaceutical packaging material units. Several entities were identified with non-compliant products, including Shanghai Guoda Dongsheng Pharmacy Co., Ltd., Shanghai Huayuan Pharmaceutical Co., Ltd., Shanghai Laiting Clinic, and Shanghai Xinren Traditional Chinese Medicine Pharmaceutical Co., Ltd., along with their respective production units like Guoyao Lerentang Hebei Pharmaceutical Co., Ltd. and Taizhou Bosheng Plastics Co., Ltd.

The main violations involved quality deficiencies in traditional Chinese medicine processed slices, such as 'Lotus Seed Heart' and 'Polygonum Multiflorum,' which failed content determination, 'Perilla Stem' with appearance issues, and several products like 'Bupleurum' and 'Dandelion' exhibiting non-compliant moisture content. Processing and general properties were also noted as issues for other traditional Chinese medicines. Furthermore, an external liquid pharmaceutical high-density polyethylene bottle was found non-compliant regarding its ethanol test solution absorbance. These issues breached standards set by the 2015 Edition of the Chinese Pharmacopoeia or specific industry standards like YBB00392003-2015.

Under the regulatory framework of the "Drug Administration Law of the People's Republic of China," the SMFDA has mandated that affected enterprises suspend sales, recall products, and implement corrective actions. Follow-up inspections will be conducted, and local market supervision bureaus will enhance oversight to ensure companies thoroughly investigate causes, rectify deficiencies, and eliminate potential risks.