Official: Check the pharmaceutical enterprises 43 times a day enterprise problems frequently.

Pharma Network August 12, August 10, according to China Quality News, the Shenzhen Municipal Market Supervision Bureau to strengthen the "drug weaponization" field of daily supervision to achieve full coverage, an average of 43 inspections per day in 2019.
Shenzhen Municipal Market Supervision Bureau issued 2019 to the Shenzhen DrugIzation (Drugs, Medical Devices and Cosmetics) production and operation of enterprises, the daily supervision and inspection of pharmaceutical enterprises, drug weaponization sampling and inspection, drug weaponization cases investigation and prosecution of the situation.
In 2019, Shenzhen organized a total of 15,845 daily supervision and inspection of drug weaponization, an average of 43 times a day;
In 2019, Shenzhen investigated and dealt with 99 cases of medical devices with a value of 7.2571 million yuan, a fine of 7.7509 million yuan, confiscation of illegal income amounting to 6.0766 million yuan, the prohibition of undocumented operations of 2 households, ordered the closure of 9 households.
, the State Administration of Market Supervision and Administration issued the "typical case of special corrective action on the quality of epidemic prevention materials and market order."
the official website, the state requires local market regulators to comprehensively check the quality of epidemic prevention materials and market order hidden dangers, and comprehensively rectify the production, circulation, consumption of outstanding problems.
the local market regulatory authorities to act quickly, continue to increase supervision efforts, strictly investigate and punish a number of illegal cases in accordance with the law, and effectively maintain the market order of epidemic prevention materials.
according to Cypress Blue Devices Observation, in this circular, the Beijing Yanqing District Market Supervision Bureau investigated and prosecuted cases of unauthorized third-class medical device business activities and operations of medical devices not registered in accordance with the law.
The parties involved in the case did not obtain the Medical Device Business License, and sold and donated a total of 95 boxes of "Coronavirus Nucleic Acid Testing Kit" and "Seven Coronavirus Nucleic Acid Testing Kits" with a total value of 93322.42 yuan.
violated the provisions of Article 31 (1) and Article 40 of the Regulations on the Supervision and Administration of Medical Devices.
in view of the timely recall of the parties "coronavirus nucleic acid testing kit" 65 boxes, the recall ratio is larger, according to the law, the total penalty for the parties about 1.408 million yuan.
The frequent problems of enterprises are based on public information statistics, "sterile" and "implanted" enterprises in the flight inspection problems frequently, belong to the "Drug Medical Device Flight Inspection Measures" Article 8 of the seventh situation: (1) complaint reports or other sources of clues indicate that there may be quality and safety risks; Where there is a risk of quality and safety; (3) adverse reactions to drugs or monitoring of adverse events of medical devices indicate that there may be a quality and safety risk; (4) there are doubts about the authenticity of the declared information; (5) there are serious violations of the requirements of quality management norms; (6) enterprises have serious non-compliance records; and (7) other circumstances requiring flight inspection.
Since the release of the Measures for Flight Inspection of Pharmaceutical Medical Devices in 2015, all flight test results have been made public on the Internet, both for the purpose of publicizing the "fair and impartial" nature of audits and, on the other hand, for the role of enterprises in the "wake-up call" industry.
From the inspection results, all of its audit basis and problems are derived from the Medical Device Site Inspection Guidelines and its appendix in 11 categories: institutions and personnel, plant and facilities, equipment, document management, design and development, procurement, production management, quality control, sales and after-sales service, non-conforming product control and adverse event monitoring, analysis and improvement, and so far no enterprise zero defects through inspection.
light time limit rectification, heavy production and rectification.
From the point of view of the principle of flight inspection, it is "two straight", that is, the inspected units shall not be informed in advance to check the itinerary and inspection contents;
it is understood that there are medical device enterprises in a month has been the Eu union announcement agency and the State Drug Administration for flight inspection, and the inspection team arrived at the company's front desk enterprises were informed.
Actually, whether it is sampling or flying inspection, are like an open-book examination, all the answers have been in the beginning of the examination of the moment, has become a final decision, if the enterprise wants to do "to check not surprise", "every inspection must pass", it must be in the enterprise's own quality and management system on strict requirements, and constantly improve and breakthrough.
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