The flight inspection of the State Food and Drug Administration of the United States is a surprise supervision and inspection carried out by the food and drug supervision and administration department on the research and development, production, management and use of drugs. Look back. In particular, check whether the traceability system of vaccines, special drugs, blood products and national centralized drugs is complete. Check the quality control of counterfeit and inferior drugs. Check the business scope, recent drug inventory management and automatic control of drug expiration date. In addition, the packaging and properties of drugs are tested in strict accordance with GSP requirements. Check the operation. Whether to provide places, qualification documents, bills and other conditions for others to illegally deal in drugs; Purchasing drugs from an individual or unit without a Drug Production License or a Drug Business License or an enterprise or institution without a Drug Registration Certificate; Selling drugs to units or individuals without legal qualifications, and still providing drugs to others knowing or should know that they are engaged in unlicensed business. Check the post. Whether the person in charge of enterprise quality and quality management personnel are on duty; Whether licensed pharmacists are registered. Check whether the cold chain drug management, drug storage and transportation records of cold chain enterprises are complete and true; Whether the storage, transportation and temperature and humidity monitoring of drugs are not carried out as required; Whether the temperature and humidity data of cold storage and refrigerated trucks can be uploaded in real time. Whether to forge the source of drug purchase, fabricate the direction of drug sales, tamper with the data of computer system and temperature and humidity monitoring system, and conceal the real records, bills, vouchers and data of drug purchase and sale. The record of drug purchase and sale is incomplete and untrue, and the business behavior cannot be traced back. I. The food and drug supervision and administration department may conduct flight inspection on the following drugs:
1, complaints or clues from other channels indicate that there may be quality and safety risks;
2, inspection found that there are quality and safety hazards;
3. Monitoring of adverse drug reactions or medical device adverse events suggests that there may be quality and safety risks;
4. There are doubts about the authenticity of the application materials;
5. Suspected of serious violation of quality management standards;
6. The enterprise has a serious record of dishonesty;
7. Other circumstances that require flight inspection. Two, if rejected, to avoid inspection is as follows:
1, delaying, restricting or refusing inspectors to enter the inspected place or area, or limiting the inspection time;
2. Failing to provide or delaying the provision of documents, records, bills, vouchers, electronic data and other materials related to the inspection without justifiable reasons;
3. Falsely telling that the personnel are absent or intentionally stopping production or business, deceiving, misleading or evading inspection;
4, refused or restricted shooting, copying, sampling and other evidence collection work;
5. Other circumstances that do not cooperate with the inspection.
Legal basis: Article 20 of the Measures for Flight Inspection of Drugs and Medical Devices is under any of the following circumstances, the inspection team shall immediately report to the food and drug supervision and administration department that organizes the flight inspection, and make a decision in time: it is necessary to increase the inspection power or expand the inspection scope; Need to take risk control measures such as product recall or suspension of research, production, sales and use; Need to initiate an investigation; Suspected crimes need to be transferred to public security organs; Other matters that need to be reported. If it is necessary to take risk control measures, the inspected entity shall take corresponding measures according to the requirements of the food and drug supervision and administration department.