The flight inspection is not closed, 509 medical supplies are canceled!

Medical Network July 26th Because the flight inspection was not closed, 2 mechanical enterprises were notified by name, and 509 medical consumable products were directly canceled!

For the flight inspection is not closed medical instruments enterprise The SFDA generally takes punitive measures such as suspension of production, business suspension, rectification, and fines. Serious cases will be imposed by administrative punishment, withdrawal of certificates, etc. However, this is only the first punishment.

In addition, Zhejiang, Sichuan, Inner Mongolia and other provinces have also adopted relevant disciplinary measures for medical device companies that are not in the process of flying inspections, and imposed a second punishment. The punishment measures are to issue a 'blocking order' directly to the product, canceling its hanging. Network qualification.

Zhejiang Province is the first province in China to issue a 'blocking order' for the company's products. It can be traced back to July last year.

In July 2017, the State Food and Drug Administration issued a notice on the suspension of production and rectification of Guangzhou Wanhe Plastic Materials Co., Ltd., and found four serious defects in its flight inspection. The company was ordered to suspend production.

Subsequently, Zhejiang Medical Machinery purchase The center suspended the online transaction qualification of the company's related products, and the first opening of the river issued a 'blocking order' for the mechanical products that did not pass the inspection.

After a lapse of one year, on July 24, 2018, Zhejiang Pharmaceutical Machinery Purchasing Center issued the “Notice on Suspension of Online Trading Qualification of Silicone Gel Scar Patches and Other Products”.

'Depending on the country drug Circular of the Supervisory Authority on the Suspension and Rectification of Shanghai Weining Plastic Products Co., Ltd. (No. 61 of 2018) and the Notice on Suspension and Rectification of Henan Yubei Eisai Co., Ltd. (No. 62 of 2018), As well as the relevant regulations on the centralized procurement of pharmaceutical equipment in our province, it is proposed to suspend the online trading qualification of products such as silicone gel scar patches.

Obviously, this is the direct release of the 'blocking order' for the products of these two enterprises, and cancels their qualification for hanging nets, and the reason is precisely because the flight inspection is not closed.

From June 26th to 29th, the State Food and Drug Administration conducted flight inspections on Shanghai Weining Plastics and Henan Yubei Weizhai. The inspection found that both companies had different degrees of general defects and serious defects.

On July 18, the State Food and Drug Administration announced the results of the inspection and ordered the two companies to immediately suspend production and rectification.

It is precisely because of the public notice of the Zhejiang Pharmaceutical Machinery Purchasing Center on July 24, directly to the two mechanical enterprises to come to an account after the fall. Name notification, and issued a 'blocking order' for its 509 products.

From the announcement of the results of the flight inspection by the State Food and Drug Administration to the issuance of the 'blocking order', the Zhejiang Pharmaceutical Machinery Purchasing Center took less than a week, and the move also released its determination to block the flight inspection but not to shut down the machinery and products. The textile products that are not inspected by the flight have issued a 'blocking order', they are serious.