# China NMPA Drug Inspection - Shanghai Fengyi Printing Co., Ltd. - Polyester/aluminum/polyethylene pharmaceutical packaging composite film

Source: https://www.globalkeysolutions.net/records/china_drug_inspection/shanghai-fengyi-printing-co-ltd/8ea6206b-2eff-4546-a4a6-92c73404125a/
Source feed: China

> China NMPA drug inspection for Shanghai Fengyi Printing Co., Ltd. published May 25, 2017. Drug: Polyester/aluminum/polyethylene pharmaceutical packaging composite film. An announcement by the State Administration for Market Regulation, published on May 25, 2017, detailed findings of subst

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## Details

- Record Type: CHINA_DRUG_INSPECTION
- Title: State Administration for Market Regulation Announcement No. 83 of 2017 Regarding 15 Batches of Substandard Drug Packaging Materials
- Company Name: Shanghai Fengyi Printing Co., Ltd.
- Publication Date: 2017-05-25
- Drug Name: Polyester/aluminum/polyethylene pharmaceutical packaging composite film
- Inspection Finding: The pharmaceutical packaging materials failed to meet standards, with the following items being unqualified: solvent residue, heat sealing strength, identification, dissolution test, and barrier properties.
- Action Taken: The relevant provincial (autonomous region, municipality) food and drug administrations have taken control measures such as sealing and seizing, requiring enterprises to suspend sales and use, recall products, and rectify the situation. The State Food and Drug Administration has required the provincial (autonomous region, municipality) food and drug administrations where the production enterprises are located to investigate the illegal acts of producing and selling substandard products in accordance with the provisions of the "Drug Administration Law of the People's Republic of China" and other regulations, and to publicly disclose the results of the handling of the relevant enterprises or units that produce and sell substandard products within three months.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/shanghai-fengyi-printing-co-ltd/a0cfe612-dd78-4692-80fc-1f787c57407b/