返回Shenzhen Urion Technology mainly produces arm and wrist electronic sphygmomanometers, infrared thermometers,
the company's two sphygmomanometer products obtained 510(K) and exported to the U.S. for about a year.
After receiving the FDA factory inspection notice, the client chose a well-known consulting firm to work with. The
client received routine training, but due to the company's foundation and management adjustments, two months
had passed, but the client company was still unable to get its hands dirty, and the procedure documents had not yet
been confirmed. The company urgently needed to be familiar with factory operations and to be able to provide
substantive counselling that would be effective in implementation.
With only one month to go, the client's preparation for the FDA factory inspection was about to come to an end.
After an urgent discussion within the customer's company, the previous FDA factory inspection counselling of the
old customer (Dongguan City, Aidisy mechanical and electrical) under the recommendation of the customer in the
third month of the time to contact us. Choose to co-operate with us.
We signed a contract with the customer, the first time to arrange the company's general counsel to the customer site
to start counselling. We helped the customer to develop a detailed FDA factory inspection preparation work plan,
according to the QSIT inspection content and internal division of labour, the formation of a working group, a clear
division of labour and timeline requirements. Then we provided a large number of practical examples, from the
discussion of DMR, DHF, DHR list and a full set of forms to provide, and then to the personnel file, procurement file,
process confirmation, CAPA, production process and instrumentation management and other modules, and
management personnel one by one to discuss. Help managers to open their mind and guide them to start their work.
After more than a month of hard work by all the staff of the client, we finally completed all the preparatory work.
During the audit, the FDA auditor conducted a detailed check on CAPA, statistical analysis of data, clinical evaluation,
510K SE comparison, and management review.
During the four-day audit, we worked together with the client every day to provide timely advice to the client and
effectively provided many predictive suggestions to avoid the risk of non-compliance in the audit.
After the four-day audit, the customer was highly appreciated by the FDA auditor and got a good result of zero
defect.
In this audit, our general consultant continuously counselled the customer at the site for more than 20 days, and
often worked overtime during the period to audit and guide the work at the customer's site.
After the audit, the three bosses of the client thanked us by phone and invited us to travel.
Through this co-operation, we have established a deep trust and comradeship with the customer. It also makes us
more firm on our service concept: to serve our customers with heart and soul, and to establish a long term and deep
cooperation relationship!
