Medical enterprises refuse to fly inspection | be canceled business license

According to Nanchang Food and Drug Administration recently notified, the Bureau organized seven high-tech zones in the medical device manufacturing enterprises, 14 medical device companies conducted a flight check, the result of 2 companies, 6 appliances Business quality management system has serious flaws.

The council also organized the West Lake District 14 medical device operators, three medical institutions conducted a flight check, the result of seven companies, one hospital The quality management system also has serious flaws.

Among them, there is an agency, the FDA informed the contents of the following:

There is a major problem: can not contact the company legal person Zhao Dejun, the company's staff Miss Yang refused to be examined (call the legal entity Zhao Dejun, the reply is not that person, call the company contact Ms. Yang, call one of the shareholders in Beijing and Did not send someone to contact law enforcement officers, law enforcement officers to send text messages to inform Ms. Yang, the reply: whatever you want.

Disposition: According to the relevant Regulations For processing

Note: to be investigated for investigation, write-off its "medical equipment business license"

Dare to refuse the flight inspection group flight check, dare to respond to law enforcement officers 'you', this business is very cattle. The consequences are also serious, to be canceled.

Check the investigation, medical companies refused to fly this thing, open case is small, but there are still some.

Jiangxi Jin Wo Biological Technology Co., Ltd., the inspection team repeatedly call corporate corporate no one answered or hung up, and finally answered, the legal person promised to send to the scene with the check but failed to pay, the inspection team to make a legal person call, can be connected , But did not answer, refused to be examined.

Jiangxi Zhongda Health Industry Co., Ltd., the telephone number connected to inform the inspection, repeatedly call repeatedly deliberately do not answer, unable to contact the person in charge.

Nanchang Zhu Kang medical technology company, refused to check, leave the scene. This is the home manufacturing enterprises.

Nanchang Yang Lin Trading Company, call the legal person, claiming to have long been closed, do not accept the inspection, whatever how to deal with.

Are very 'bold', of course, so dry business, will also be handled in accordance with relevant laws and regulations.drug medical instruments Flight inspection approach "there is about 'evasion, refused to check the situation' clearly defined.

Early last year, Anhui Food and Drug Administration has issued a circular, a pharmaceutical factory in the province after the arrival of the flight test group to take the lock, pull the curtain to block the inspectors on-site inspection, there is no justifiable reason not to provide stock ledger, sales counter Accounts and other materials.The inspection team was forced to interrupt the inspection.

Ultimately, the behavior of the pharmaceutical company was found to evade, refused to check, the test results should be inconsistent with the GMP standard drugs, the Food and Drug Administration decided to withdraw enterprise GMP certificate, and further investigation and processing.

Medical device flight check this piece, the State Drug Administration had a public release, to continue to strengthen the third category of medical equipment manufacturing enterprises and complaints due to circumstances such as the flight check and timely fly the first category, The second category of manufacturing enterprises, focused on the operation of flight inspections should also be organized.

However, at the SFDA level, it is also obvious that there are more and more flight inspections for the enterprises, manufacturers and medical institutions.

For example, Nanchang, a city, this year the drug regulator has issued a total of seven flying inspection announcement, involving 25 companies, 90 companies, 11 medical institutions.

In the future, there will be more and more flying inspections and more and more professional inspectors. Medical enterprises also want to do a good job in the industry. 'Evasion and refusal of flying tests' will not work!