State Food and Drug Administration for medical equipment manufacturing enterprise flight inspection action, has been nearly two months without movement. However, the mechanical enterprises do not relax vigilance, happy too early. Because the drug based on the previously revealed the news, GMP medical flying as early as the Mid Autumn Festival, still have to continue.
The State Bureau of medical GMP fly what it means to check? Jiangsu Province, Yangzhou city food and drug administration gives a out of the ordinary answer: a problem, the city's move it self correction.
June 23, 2016 to 25, the State Food and Drug Administration conducted flight inspection of Yangzhou Huanyu medical instrument limited company, found that there are a number of defects of the enterprise quality management system, the key is 2, 9, reached the standard of production for rectification.
In September 19th, the Jiangsu provincial food and Drug Administration issued the "Jiangsu provincial food and Drug Administration of Yangzhou Huanyu medical instrument limited company discontinued rectification notice" (Su SFDA tube 2016 No. 204).
Notice that, according to the National Bureau of flight inspection report, Jiangsu province food and Drug Administration and the Yangzhou bureau to do the following work:
The State Council issued to Yangzhou universal medical instrument limited company, received a notice to stop production for rectification, Yangzhou city food and drug administration is the first time to notify the company immediately suspend production for rectification, the company is currently being planned for rectification.
Two, the Yangzhou Municipal Food and drug administration not only interviewed the person in charge of the enterprise, and urge enterprises to require rectification, also held in the city of medical equipment manufacturing enterprises warning mobilization meeting, all production enterprises require careful self-examination, strictly implement the medical GMP specification, quality management system to ensure effective operation.
Jiangsu province and Yangzhou City Bureau will also pay close attention to stop production for rectification, and urge enterprises in accordance with the relevant provisions of GMP medical norms rectification in place. At the same time, increase the track inspection efforts, the necessary time to organize the flight inspection. To be the completion of the company to complete the rectification of all defects, the provincial food and drug administration to organize follow-up inspection after passing, the party can resume production.
As mentioned above, Yangzhou city food and Drug Administration warning mobilization on the city's mechanical enterprises, all requirements of GMP standard implementation of medical self correction.
In the face of such a flight check, are you scared?