7 companies such as China Resources and Xi'an pharmaceutical had problems in flight inspection, and the GSP certification was revoked

Recently, the official website of the State Drug Administration released a batch of flight inspection notices for pharmaceutical enterprises Seven pharmaceutical enterprises, including China Resources Xi'an Pharmaceutical Co., Ltd., were revoked the GSP certificate in accordance with the law due to their serious violation of the drug trade quality management specifications According to the flight inspection of China Resources Xi'an Pharmaceutical Co., Ltd conducted by the inspection center of the State Food and drug administration, the enterprise purchased some drugs before the completion of the legitimacy audit During the spot check of 100 boxes of compound infantile antipyretic suppository and vitamin b12600 boxes purchased by the enterprise, it was found that the enterprise did not establish the above drug database in the computer system, and purchased the drugs without completing the drug legitimacy audit, and did not purchase the drugs through the computer system In flight inspection of Jixi Chenxi Pharmaceutical Co., Ltd., it was found that the historical data of temperature and humidity in the cold storage of the enterprise was more than 5 ℃, in which there were drugs that needed to be stored at 0-5 ℃ Gansu Boxiang Pharmaceutical Co., Ltd has some problems, such as the enterprise does not confirm the legal qualification of the supplier and the purchased drugs, and does not verify the legal qualification of the sales personnel of the supplier During the flight inspection, it was found that the enterprise room temperature warehouse of Tianshui Kangtai Pharmaceutical Co., Ltd was not equipped with temperature control equipment The data entry, modification and preservation of the computer system of Dazhou Chaoyang pharmaceutical Co., Ltd cannot guarantee the authenticity, accuracy and traceability of the data In addition, the flight inspection of Loudi Minkang Pharmaceutical Co., Ltd found that the two incubators equipped by the enterprise did not have the function of external temperature display, nor could they collect, display, record and transmit the temperature data in the process of transportation in real time, nor could they read and store the monitoring data through the computer terminal Hefei dunk biomedical Co., Ltd did not issue a true invoice for the sale of drugs, and failed to achieve the consistency of the invoice, account, goods and funds In 2016, the enterprise sold ceftazidime for injection to Guoyao Holding Co., Ltd and issued a 30 point VAT special invoice The name of the goods on the invoice is "a batch of drugs" The names of the goods listed in the VAT goods and taxable services list are "Cordyceps" and "Ma card" All of the above-mentioned seven pharmaceutical enterprises have seriously violated the quality management specifications for drug distribution and have been revoked the GSP certificate according to law.