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The State Drug Administration ordered Guangzhou Caijie Cosmetics Co., Ltd. to suspend business for rectification

浏览量:447 来源:界面新闻 编辑:广州澳歌立可植物技术开发有限公司 Post time: 2019-08-20 Views: 447 Source: Interface News Editor: Guangzhou Aoge Li Ke Plant Technology Development Co., Ltd.

According to the website information of the State Drug Administration, recently, the State Drug Administration organized a flight inspection of Guangzhou Caijie Cosmetics Co., Ltd. During the inspection, it was found that the company severely violated the relevant provisions of the “Cosmetics Production Licensing Work Rules”, and the quality management system mainly has the following defects:

I. Institutions and personnel

The person in charge of production of the enterprise was unfamiliar with part of the production process and failed to perform the corresponding duties.

Plant and facilities

(1) There is no temperature and humidity monitoring equipment and records in the packaging materials warehouse. Some areas are leaking rain, and there is water on the ground. There are no facilities for preventing rats, insects, dust, and moisture.

(2) Each functional area of the production area does not strictly distinguish the flow of people and logistics. Operators can enter and exit each production area at will, which cannot effectively avoid cross-contamination.

(3) The air outlet of the emulsification workshop and the outlet of the sewage pipe directly communicate with the outside through the wall, and the opening is large, which cannot effectively prevent pollution. A live cockroach was found on the outer wall of the emulsifying pot.

(4) The enterprise has not established a finished product warehouse. The two open-air simple tents built in the factory yard are stacked with finished products and packaging materials, and the ground is humid and watery.

Third, equipment management

(I) The emulsification pot and the material conveying pipeline are not cleaned thoroughly, there are materials remaining, the surface of the motor is stained and the wires are exposed; gloves, rusty screwdrivers, paper towels and other debris are stacked on the top of the emulsification pot.

(2) Some measuring instruments have not been verified, such as a digital electronic scale used in the filling room for production process inspection, and a pressure gauge for a homogeneous mixing pot in the production room.

(3) Records of regular cleaning, maintenance and disinfection of the anhydrous treatment system.

Fourth, materials and products

(1) The enterprise failed to evaluate and inspect the salicylic acid supplier in accordance with the provisions of the Material Supply Management System.

(2) The identification information of the semi-finished product storage tank is incomplete. For example, the semi-finished product storage tank with the product name "Caijie Hair Cream B" only identifies 2019, without a specific production date and expiration date.

(3) Samples are not retained as required, such as Han Xiu essential oil batik (batch number: CJ2019061001) and Caijie color tea aroma dye (batch number: CJ2019061001).

V. Production Management

The enterprise has not strictly implemented the production process regulations, and there is an act of changing the formula of the administrative license for special purpose cosmetics without approval.

The enterprise has confirmed the defects in the above quality management system. The above-mentioned behavior of the enterprise seriously violated the relevant provisions of the “Cosmetics Production Licensing Work Regulations”. The State Drug Administration ordered the Guangdong Drug Administration to order the enterprise to suspend the production and sales of all cosmetics , and seriously deal with suspected illegal and illegal production activities of the enterprise according to law. Production and sales can only be resumed after the enterprise has completed all project rectifications and passed the follow-up review by Guangdong Drug Administration.

announce.

State Drug Administration

August 2, 2019