Special inspections of Nanchong Correctional Testing agents, samplers and sampling tubes

Since the "8.21" epidemic in Nanchong, the detection volume of the new crown virus nucleic acid in Nanchong City has increased sharply, and the amount of detection reagents, samplers and sampling tubes has increased significantly. Special inspections of related products were carried out.

Sichuan Zhuoxi Biological Research Center is the only company in Nanchong City that produces a virus sampling tube at one time. Inspectors, the inspectors focused on whether the company's raw material procurement channels were compliant, whether the production process was standardized, whether the inspection was strictly implemented, whether the finished product release met the requirements, whether the finished product was stored in accordance with the standards, whether the "four must check" epidemic prevention measures, etc. Essence

The inspectors focused on whether the purchase channels for the new coronary virus test agent, sampler, and sampling tube were legal, whether it was established and preserved in accordance with regulations, and the real and complete procurement and acceptance records were preserved; Seek and check whether the product -related qualification materials, whether the product is valid; whether the transportation and storage conditions meet the labels and the label requirements of the instructions, whether it is equipped with compatible facilities and equipment; whether to carry out the supervision of adverse events in medical device in accordance with regulations.

This special inspection operation dispatched 1694 law enforcement officers to conduct a comprehensive inspection of 548 nucleic acid samples of a disposable virus sampling management manufacturer and 75 nucleic acid testing agencies in the city, and the inspection coverage reached 100%. From the overall situation of inspection, various laws and regulations such as the "Regulations on the Supervision and Administration of Medical Devices" of various production and operation enterprises are better. No purchase of raw materials from illegal channels, product labeling specifications, nucleic acid detection agencies and nucleic acid sampling points have not been found to be invalidated or used to be invalidated or found out. The new coronal virus test agent, sampler, and sampling tube with quality problems exist. All units are purchased from legal channels and related notes, documents prove the number of products, prices and product quality.

In response to individual nucleic acid testing laboratories and sampling points, the laws and regulations of employees were weak, medical equipment was unconventional, data collection was not complete, and the archives management was not perfect. Law enforcement officers conducted on -site training and guidance to order rectification within a time limit. A total of 36 rectifications were ordered to be rectified within a time limit. (Yu Qingping)

- END -