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On September 11th, the Guangxi Provincial Drug Administration published the Decision on Administrative Punishment of the Drug Administration of Guangxi Zhuang Autonomous Region (Spike Plastic Factory - Pharmaceutical Packages).
, Nanning City, China, batch number: 20190705, production date: 2019.07.05, specification: 140×0.05mm polyester /Low density polyethylene medicinal composite film by Guangxi Zhuang Autonomous Region pharmaceutical packaging materials container product testing center in accordance with the "National Pharmaceutical Package Standard" (YBB00182002-2015) inspection project "barrier performance" water vapor through the amount does not meet the requirements.
penalty decision shows that the non-conforming composite film in Guangxi Runda Pharmaceutical Co. , Ltd. sampling, marking the production unit for Nanning City Spike plastic color printing packaging plant.
law enforcement officials on January 13, 2020 on-site inspection of the parties, confirmed that the above-mentioned polyester / low density polyethylene pharmaceutical composite film for the parties to produce, a total of 483.7 kg, all sold to Guangxi Runda Pharmaceutical Co., Ltd., no inventory.
the production and sale of non-conforming pharmaceutical packages by the parties in violation of Article 2 of the Measures for the Administration of Packaging Materials and Containers for Direct Contact with Drugs, the production, import and use of pharmaceutical packages must comply with the provisions of the national standards.
fined a total of 10,000 yuan (US$20000.00).
the source of the case, the investigation and the administrative coercive measures taken in accordance with the "Guangxi Zhuang Autonomous Region Pharmaceutical Packaging Materials Container Product Testing Center Inspection Report" (report number: YB2019Cj0196/YB2019Cj0196-FY ) shows that on September 26, 2019 in Guangxi Runda Pharmaceutical Co., Ltd., the identification of the production unit for Nanning City Spike Plastic Color Printing Packaging Factory, polyester / low density polyethylene pharmaceutical composite film inspection project "barrier performance" water vapor through the amount does not meet the requirements.
law enforcement officials on January 13, 2020 on-site inspection of the parties, confirmed that the above-mentioned polyester / low density polyethylene pharmaceutical composite film for the parties to produce, a total of 483.7 kg, all sold to Guangxi Runda Pharmaceutical Co., Ltd., no inventory.
the production and sale of non-conforming pharmaceutical packages by the parties in violation of Article 2 of the Measures for the Administration of Packaging Materials and Containers for Direct Contact with Drugs, the production, import and use of pharmaceutical packages must comply with the provisions of the national standards.
violation of laws, regulations or regulations On July 5, 2019, the parties produced batch number: 20190705, production date: 2019.07.05, specification: 140× 0.05mm polyester/low density polyethylene pharmaceutical composite film 483.7Kg, and on July 8, 2019 sold to Guangxi Runda Pharmaceutical Co., Ltd. at a price of 24.00 yuan per kilogram, earning 11608.08 yuan.
The nature of the case, discretionary facts and reasons according to the report shows that polyester / low density polyethylene medicinal composite film by the Guangxi Zhuang Autonomous Region pharmaceutical packaging materials container product testing center in accordance with the "National Drug Package Standard" (YBB00182002-2015) inspection project "barrier performance" water vapor through the amount does not meet the requirements.
According to the inspection conclusions of the above-mentioned Inspection Report, the polyester/low density polyethylene medicinal composite film produced by the parties (lot number: 20190705) violates Article 2 of the Measures for the Administration of Packaging Materials and Containers for Direct Contact With Drugs, and the above-mentioned polyester/low density polyethylene medicinal composite film (lot number: 20190705) is an unqualified pharmaceutical package.
the parties sold the above-mentioned non-conforming pharmaceutical packages to Guangxi Runda Pharmaceutical Co., Ltd. on July 8, 2019, and imposed penalties in accordance with the provisions of Article 64(2) of the Measures for the Administration of Packaging Materials and Containers for Direct Contact with Drugs.
The polyester/low density polyethylene medicinal compound film (lot number: 20190705) in this case was tested as unqualified, the parties were legitimate enterprises, the product was also tested and released, there is no serious and light situation.
The contents of the administrative penalty and the production and sale of non-conforming polyester/low density polyethylene medicinal composite film by the parties violate the provisions of Article 2 of the Measures for the Administration of Packaging Materials and Containers for Direct Contact with Drugs, and the following administrative penalties are given to the parties in accordance with the provisions of Article 64(2) of the Measures for the Administration of Packaging Materials and Containers for Direct Contact with Drugs: 1, in accordance with The Provisions of Article 23 of the Administrative Penalty Law of the People's Republic of China, the company shall be ordered to stop producing non-conforming medicines.
2, fined 10,000 yuan (¥20,000.00).