China NMPA Drug Inspection - Anhui Yuanshantang Pharmaceutical Co., Ltd. - Atractylodes macrocephala

The Shanghai Municipal Food and Drug Administration (SMFDA) released its 2017 Issue 2 Drug Supervision and Sampling Inspection Quality Announcement on June 1, 2017. This announcement summarized quality supervision inspections performed on drug and pharmaceutical packaging material manufacturers and distributors across Shanghai during the second quarter of 2017. Numerous companies, including Shanghai Yutiancheng Traditional Chinese Medicine Slices Co., Ltd., Shanghai Hongqiao Traditional Chinese Medicine Processing Co., Ltd., and Shanghai Tongjitang Pharmaceutical Co., Ltd., were cited for significant quality non-conformities. Among the 24 substandard traditional Chinese medicinal products identified, common violations included non-compliance with standards for Aflatoxin content, Appearance, Processing, Content Determination, Properties, Moisture content, Total Ash, Sulfur Dioxide Residue, and Impurities. Notably, Platycladus orientalis seed and Arborvitae Seed slices contained unacceptable levels of Aflatoxin. The regulatory framework for these inspections was the *Drug Administration Law of the People's Republic of China*, supplemented by various editions of the *Chinese Pharmacopoeia* and *Shanghai Processing Regulations*. Consequently, affected enterprises were directed to halt sales and use, recall deficient products, and undertake immediate rectification. The SMFDA further committed to intensified follow-up inspections and daily oversight, compelling companies to thoroughly investigate underlying causes and implement robust corrective measures to eliminate potential risks.