China NMPA Drug Inspection - Shanghai Zhenrentang Pharmaceutical Co., Ltd. - Bupleurum

The Shanghai Municipal Food and Drug Administration (SMFDA) released its 2018 First Quarter drug supervision and sampling inspection results on January 31, 2018. These inspections focused on drug and pharmaceutical packaging material units across Shanghai to uphold market quality and safety. Numerous companies, including Guangdong Xianqiang Pharmaceutical Co., Ltd., Bozhou Haomen Traditional Chinese Medicine Slices Co., Ltd., Anhui Yiyuantang Traditional Chinese Medicine Slices Technology Co., Ltd., Tianjin Boai Biopharmaceutical Co., Ltd., Shanghai Xinya Pharmaceutical Minhang Co., Ltd., Shanghai Hongli Pharmaceutical Packaging Materials Co., Ltd., and Shanghai Jiurong Plastic Products Co., Ltd., were found non-compliant.

Key issues for drug products encompassed 'Related Substances' (e.g., Meclofenac Hydrochloride Capsules), 'Sulfur Dioxide Residue' (e.g., Honeysuckle), 'Appearance' and 'Processing' defects prevalent in traditional Chinese medicine slices, 'Content Determination' inaccuracies (e.g., Processed Polygonum multiflorum Slices, Pediatric Acetaminophen and Chlorpheniramine Maleate Granules), 'Weight Discrepancy' (e.g., Pu Dilan Anti-inflammatory Tablets), and 'Content Uniformity' (e.g., Clobetasol Propionate Cream). Pharmaceutical packaging material issues included 'Solvent Residue,' 'Sealing Performance,' and 'Water Vapor Permeability.'

These violations were assessed against the *Drug Administration Law of the People's Republic of China*, the 2015 Edition of the Chinese Pharmacopoeia, and specific Shanghai Processing Regulations and National Drug Standards. The SMFDA mandated that affected enterprises suspend sales, recall products, and implement corrective actions. Further, the administration committed to enhanced follow-up inspections and collaboration with local bureaus to ensure root cause investigation and risk mitigation.