Guizhou Provincial Drug Administration announced a group of typical cases of special rectification of drug safety

Colorful Guizhou News (reporter Wu Wei on this website) On July 14, the reporter learned from the Guizhou Provincial Drug Administration that since this year, in accordance with the deployment requirements of the State Drug Administration, the main line is to strictly investigate illegal and strictly control risks. Guizhou is the main line. Guizhou is the main line. The Provincial Pharmaceutical Supervision and Administration Bureau has conducted in -depth rectification operations throughout the province, quickly acts in various places, strengthens regulatory law enforcement efforts, digs deeply for illegal and illegal clues, investigates a number of violations of laws and regulations in accordance with the law, and effectively maintains drug safety and the people of the people. Life is healthy.

The first batch of special rectification of drug safety rectification is announced:

1. Guizhou Jianruian Pharmaceutical Co., Ltd. violated the quality management specifications of drug production

In December 2021, the Guizhou Provincial Pharmaceutical Supervision Bureau found that Guizhou Jianrui An Pharmaceutical Co., Ltd. found that the company had no quality assessment of some material suppliers and did not follow the purchase of materials for some material suppliers. It stipulates that the existence of the enterprise warehouse, the changes of some intermediate storage periods in accordance with the results of the stability inspection, and the market sales and return drugs are not stored in the corporate warehouse and the quality assessment is not performed in accordance with the document requirements. Yang Moudong, the person in charge of the enterprise and the person in charge of the enterprise, was not in place for the daily management of the enterprise, and failed to effectively fulfill the relevant management responsibilities. The company's above -mentioned behavior violated Article 45, paragraph 1, and Article 43 of the Drug Administration Law. In July 2022, the Guizhou Provincial Drug Administration stipulated in Article 126 of the Drug Management Law, which was punished by the company's fine of 500,000 yuan, suspended production, and rectification. A total of 41,800 yuan of administrative penalties for fines and confiscation of illegal income.

2. Guizhou Kyushu Tongyi Yaotang Pharmaceutical Co., Ltd. provides false information to fraudulent drug business licenses

In September 2021, the Fenggang County Market Supervision Bureau found in daily supervision and inspection that the Kyushu Tongyi Yaotang Pharmaceutical Co., Ltd. Fenggang Branch could not provide a license to a practicing pharmacist at the scene. Provide false materials, Fenggang County Market Supervision Bureau also transferred the clue to Fenggang County Comprehensive Administrative Law Enforcement Bureau for handling. After investigation, the company's "Certificate of Resignation", "Personal Resume" and "Hire" and other false information by the person in charge of the company and the person in charge of the quality of the company deceived the Drug Business License. The company provides false information to deceive the drug business license and violates Article 7 of the Drug Management Law. Executive penalties with a fine of 50,000 yuan. Fenggang County Market Supervision Bureau revokes the company's drug business license in accordance with Article 123 of the Drug Administration Law.

3. Liu Mougang, Changshun County, to purchase traditional Chinese medicine drinks from enterprises with no drug operating qualifications

In April 2022, the Changshun County Market Supervision Bureau found in the inspection of special rectification of drug safety and found that Liu Mougang's Chinese medicine cabinets in the Chinese Medicine Clinic were stored in American ginseng tablets, Ophiopogon, and Sichuan Fritillaria 12 packaged in transparent plastic bags 12 There is no labeling Chinese medicine decoction, and it cannot provide materials such as product supplier qualifications, purchasing bills and other materials. After investigation, the parties purchased the above 12 types of Chinese medicine drinks from the Yunnan Chinese medicinal materials planting base for diagnosis and treatment activities. They were purchased by primary agricultural products. They could not provide suppliers' qualification materials and follow -up lists. The value of the goods involved was 1643.42 yuan. The parties' behavior of purchasing Chinese medicine tablets from non -drug business qualifications violates Article 55 of the Drug Administration Law. According to Article 129 of the Drug Administration Law Administrative penalties of the parties confiscated illegal Chinese medicines and fined 10,000 yuan.

Fourth, Chishui People's Hospital uses the case that does not meet the compulsory standard medical equipment case

In November 2021, the Zunyi Market Supervision Bureau supervised and sampled the "Disposable Medical Protection Server" used by Chishui People's Hospital. After inspection by the Provincial Medical Device Inspection Center, the batch number 20210428 "One -time Medical Protection Server" The inspection project does not comply with the provisions of the GB19082-2009 "Technical Requirements for Medical One-time Protective Server". The Zunyi Market Supervision Bureau transferred the clue to the Chi Shui City Comprehensive Administrative Law Enforcement Bureau. After investigation, Chishui People's Hospital purchased 400 sets of "one -time medical protection clothing" from Jiangxi Yuehui Medical Device Co., Ltd., with a value of 13,400 yuan in the case. The hospital uses the behavior that does not meet the mandatory standard medical equipment, and violates Article 7 of the Regulations on the Supervision and Administration of Medical Device. The item stipulates that the hospital shall confiscate the administrative penalty of the products involved and a fine of 80,000 yuan.

5. Guizhou Qicong Listening Equipment Co., Ltd. has not been permitted to engage in three types of medical device operations and engaged in medical device network sales in accordance with regulations.

In February 2022, Liupanshui Market Supervision Bureau reported suspiciously in accordance with the national medical device network sales monitoring platform, and inspected Guizhou Qicong Listening Equipment Co., Ltd. and found that the company registered medical equipment on the online store line through Meituan APP. The drug regulatory authorities at or above the county level are not filed; there are no three types of medical device business qualifications to sell three types of medical devices "Human immune defect virus antibody (HIV1/2), and the value of the case involved is 2395 yuan. The company's above behavior violates the" " Article 42 of the Regulations on the Supervision and Administration of Medical Devices and Article 7 and 8 of the "Measures for the Supervision and Administration of Medical Device Network Sales" stipulates that the Liupanshui Market Supervision Bureau shall be in accordance with Article 81 of the Regulations on the Supervision and Administration of Medical Device ( 3) Article 39 of the "Measures for the Supervision and Administration of Medical Device Network Sales Sales" stipulates that the company's administrative penalties for warning, confiscation of illegal income and illegal operations, and a fine of 5,000 yuan. Xinggui Chinese and Western Pharmacy is not permitted to engage in the third category of medical device business activities

In January 2022, the Bijie Market Supervision Bureau during the special rectification operation of drug safety in the spring of drug safety, during the inspection of Xinggui Chinese and Western pharmacies in Hei Town, Weinjin County, found that the manufacturer was labeled in the back -side room of the pharmacy. Institutional Group Co., Ltd., the production registration certificate number is 37 sets of "disposable use of infusion with needle" and sold 13 sets of 20193141756. The parties did not obtain the "Medical Device Business License" to sell the third category of medical devices, and violated the provisions of Article 42, paragraph 1 of the "Regulations on the Supervision and Administration of Medical Device", and Bijie Market Supervision Bureau in accordance with the "Medical Device Supervision and Management The Regulations "Article 81, paragraph 1, paragraph 3, stipulates that the parties confiscate illegal products, confiscate illegal income, and fine 70,000 yuan.

7. Shi Mou, Bijie City, operates more than the cosmetics case of the use period

In December 2021, the Bijie Market Supervision Bureau received a reflection of the "Pinduoduo" platform transferred to the merchant "Aya's Grocery Shop" to sell more than the use of cosmetics for cosmetics. "Platform register" Aya's Grocery Store "online operating cosmetics (no business license). During the period, the reporter sold 5 boxes of" Weinna sunscreen "that exceeded the period of use, and the value of the case involved was 60 yuan. The parties operate more than the cosmetics behavior of the use period, and violates Article 39 of the Regulations on the Regulations on the Administration of Cosmetics. The Bijie Market Supervision Bureau shall pay the parties in accordance with the provisions of Article 60 (5) of the "Cosmetics Supervision and Administration Regulations". Administrative penalties with illegal income and fines of 18,000 yuan.

8. Kaili Devin Daily Management Department operates more than the use period cosmetics case

In June 2021, the Qiandongnan Prefecture Market Supervision Bureau and the State Public Security Bureau jointly launched a special operation to combat fake and shoddy cosmetics, found a large number of shampoo cosmetics in the warehouse of the German daily chemical operation department in Kaili, and found sales at the sales venue. Shampoo cosmetics exceeding the use period cannot provide purchase notes and related inspection records, and some cosmetics marks have two use periods. The parties have not established and implemented the inspection record system of the purchase, and the operation of the operation of the cosmetics that exceeds the period of use and labels does not meet the regulations. Article 18, paragraph 1, and Article 39 stipulates that in accordance with Article 60 (5), Article 61 (5) of Article 60 (5), (5), in accordance with the "Cosmetic Supervision and Administration Regulations" , Paragraph No. 62 (2), refer to the "Application Rules for the Application of the Administrative Penalty Administrative Punishment of Drug Supervision and Administration (Trial)" (1), paragraph (1), in accordance with the provisions of Article 10 (1) The party warned, confiscated illegal cosmetics, and fined 40,000 yuan in administrative penalties.

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