China NMPA Drug Inspection - Xi"an Jifeng Pharmaceutical Packaging Co., Ltd. - Polyester/aluminum/polyethylene pharmaceutical packaging composite film

An announcement by the State Administration for Market Regulation, published on May 25, 2017, detailed findings of substandard drug packaging materials following inspections by the Jiangxi Provincial Institute for Drug Control. A total of 15 batches from 14 companies were identified as non-compliant. Key manufacturers implicated include Tianjin Litian Pharmaceutical Packaging Materials Co., Ltd., Tianjin Baode Packaging Co., Ltd., and Dalian Ronghua Color Printing & Packaging Co., Ltd., among others, producing various pharmaceutical packaging films. The primary violations involved critical quality attributes such as excessive solvent residue, inadequate heat sealing strength, identification issues, deficiencies in leachate tests, and compromised barrier properties. In response, provincial food and drug administrations initiated immediate control measures, including product sealing, seizure, suspension of sales and use, and mandatory product recalls, along with rectification requirements for the manufacturers. Operating under the authority of the 'Drug Administration Law of the People's Republic of China,' the State Food and Drug Administration mandated that local administrations investigate these illegal activities. They are required to publicize the resolution of these cases within three months and report findings back to the national administration, ensuring accountability and adherence to regulatory standards for pharmaceutical packaging safety.