China NMPA Drug Inspection - Shanghai Lei Yunshang Chinese Herbal Medicine Factory - Qianhu

The Shanghai Municipal Food and Drug Administration (SMFDA) announced on June 1, 2017, the results of its second-quarter drug supervision and sampling inspections for 2017. These inspections focused on drug and pharmaceutical packaging material producers, operators, and users across the city, aiming to reinforce quality and market order. Numerous companies, including Shanghai Yutiancheng Traditional Chinese Medicine Slices Co., Ltd., Shanghai Lei Yunshang Pharmaceutical Chain Operation Co., Ltd., and Shanghai Tongjitang Pharmaceutical Co., Ltd., were found non-compliant. The main violations centered on traditional Chinese medicinal materials and processed slices. Key issues identified included unacceptable levels of aflatoxin, failures in appearance and processing standards, inaccurate content determination, and deficiencies in properties, moisture content, total ash, sulfur dioxide residue, and impurities in various products. These findings were evaluated against the *Drug Administration Law of the People's Republic of China*, specific editions of the *Chinese Pharmacopoeia* (2010 and 2015), and the *2008 Edition Shanghai Processing Regulations*. In response, enterprises were directed to suspend sales, recall affected products, and promptly rectify the identified problems. The SMFDA committed to subsequent follow-up inspections and mandated local market supervision bureaus to oversee the investigation of root causes, the formulation and execution of rectification plans, and the elimination of potential risks to ensure sustained drug quality and safety.