State Food and Drug Administration Flight Inspection is a supervisory inspection carried out by the Food and Drug Administration (FDA) for the development, production, operation and use of drugs without prior notice.
In 2006, the former State Food and Drug Administration issued the Interim Provisions on Flight Inspection of Pharmaceutical GMP (SFDA_2006_165), and in 2012, it issued the Working Procedures for Flight Inspection of Medical Devices Manufacturing Enterprises (Trial) (SFDA_2012_153), which have played an important role in investigating problems, controlling risks and deterring violations.
The General Administration of Food and Drug Administration (GFDA) initiated the drafting of the Measures for Flight Inspection of Pharmaceuticals in September 2013, and the draft was put on the website of GFDA on May 12, 2014 for comments. After further modification and improvement, it was openly solicited for comments on the Chinese Government Legal Information Network from November 3 to December 4, and a total of 147 comments were collected. After study, the regulations were renamed as Measures for Flight Inspection of Drugs and Medical Devices, and the contents were adjusted and modified accordingly.On May 18, 2015, the Measures were adopted by the Bureau Meeting of the Food and Drug Administration.
Extended Information
The Measures for Flight Inspection of Drugs and Medical Devices states:
Article 20? One of the following circumstances, the inspection team shall immediately report to the organization of the implementation of flight inspection of food and drug supervision and management department to make a timely decision:?
(a) the need to increase the inspection force or extend the scope of inspection;?
(ii) the need to take product recall or suspend the development, production, sale, use and other risk control measures;?
(C) the need to file an investigation;?
(d) suspected of a crime that needs to be transferred to the public security organs;?
(v) Other matters that need to be reported.?
The need to take risk control measures, the inspected unit should be in accordance with the requirements of the food and drug supervision and management department to take appropriate measures.?
Article 21? The time of on-site inspection shall be determined by the inspection team according to the inspection needs, in order to be able to find out and investigate the problem as a principle.
Only after the consent of the food and drug administration department that organizes and implements the flight inspection, the inspection team can end the inspection.
Baidu Encyclopedia - Flight Inspection of Drugs
Suxian District People's Government - Flight Inspection of Drugs and Medical Devices