China NMPA Drug Inspection - Tonghua Sanxin Plastic Packaging Co., Ltd. - Polyester/low-density polyethylene composite film for pharmaceutical packaging (batch number 201700518)

The State Administration for Market Regulation issued Announcement No. 200 of 2017 on December 8, 2017, detailing findings from inspections of drug packaging material manufacturers. Six companies were identified for producing substandard products. These companies include Qinhuangdao Zebao Pharmaceutical Packaging Co., Ltd., Xianyang Zhuoyue Plastic Printing Co., Ltd., Xi'an Jifeng Pharmaceutical Packaging Co., Ltd., Tonghua Sanxin Plastic Packaging Co., Ltd., Tianjin Dede Pharmaceutical Packaging Co., Ltd., and Xuzhou Longrun Pharmaceutical Packaging Co., Ltd. The primary violations involved the failure of polyester/polyethylene and polyester/low-density polyethylene pharmaceutical packaging composite films to meet quality standards, specifically concerning barrier performance and solvent residue. In response, provincial food and drug administrations implemented immediate control measures, including sealing and seizing the affected products. The companies were mandated to cease sales, recall the non-compliant materials, and implement corrective actions. Operating under the regulatory framework of the Drug Administration Law of the People's Republic of China, the State Food and Drug Administration (SFDA) further directed the provincial authorities to investigate these companies for illegal activities related to the production and distribution of substandard goods. Authorities are required to publicly disclose their handling results within three months and report findings to the SFDA promptly.