China NMPA Drug Inspection - Tianjin Pacific Pharmaceutical Co., Ltd. - Glibenclamide tablets

On August 13, 2020, the Anhui Provincial Drug Administration released the second issue of its 2020 Drug Quality Bulletin, detailing the results of recent random inspections across the province's drug production, distribution, and healthcare facilities. The audit identified five drug batches that failed to meet established quality benchmarks. The manufacturers involved include Bozhou Gongyao Decoction Pieces Factory, Bozhou Shenghai Traditional Chinese Medicine Pieces Co., Ltd., Henan Jinhongtang Pharmaceutical Co., Ltd., Anhui Yijiantang Traditional Chinese Medicine Pieces Technology Co., Ltd., and Tianjin Pacific Pharmaceutical Co., Ltd. Under the regulatory framework of the Chinese Pharmacopoeia (2015 Edition) and specific provincial processing standards, inspectors identified several critical quality violations. Major issues included insect infestations resulting from improper storage at retail pharmacies, excessive moisture content, microbial contamination exceeding safety limits, and the presence of impurities (related substances) in pharmaceutical tablets. Some traditional medicine samples also failed physical identification assessments. Following these findings, provincial and local drug regulatory authorities have initiated formal investigations into the non-compliant products and the responsible entities. Required actions include the ongoing legal handling of these violations to ensure public safety and the enforcement of stricter compliance with drug quality and storage protocols.