China NMPA Drug Inspection - Sichuan Pharmaceutical Co., Ltd. - jellyfish

The Chongqing Municipal Food and Drug Administration issued its 2017 Issue No. 5 Drug Quality Announcement on October 16, 2017, detailing results from recent drug sampling inspections. These inspections, conducted by various food and drug regulatory departments, aimed to bolster drug quality oversight, maintain market integrity, and safeguard public health.The announcement identified numerous drug products from multiple manufacturers that failed to meet established quality standards. Key companies cited include Tianjin Biochemical Pharmaceutical Co., Ltd. for Amikacin Sulfate for Injection, Liaoning Tianyi Biopharmaceutical Co., Ltd. for Butianling Tablets, and several Sichuan-based companies like Sichuan Juyuan Traditional Chinese Medicine Pieces Co., Ltd. for various traditional Chinese medicine pieces. Violations were diverse, encompassing failures in solution clarity, disintegration time, and identification tests. Additionally, issues such as unacceptable levels of magnesium salts, aluminum salts, total ash, sulfur dioxide residue, pentachloronitrobenzene, and other impurities were detected. Some products also exhibited non-compliance in their physical properties or active ingredient content.These deficiencies highlight a failure to adhere to the stringent requirements set forth by the Chinese Pharmacopoeia (primarily the 2015 and 2010 editions) and supplementary inspection methodologies. While specific enforcement actions for individual companies are not detailed, the publication of these findings serves as a public notification, implying the necessity for manufacturers to recall non-compliant batches, investigate root causes, and implement robust corrective and preventive actions to ensure future product quality and patient safety.