返回Dongguan JIATE Medical Instruments is a professional manufacturer of various dental disposable consumable
products, which is a subsidiary factory of Wanlian International Co.
Founded in 2002, the company has several production workshops such as injection moulding, extrusion moulding,
tube drawing, film blowing, mouthpiece, hair stick, automatic assembly, etc. It is one of the earlier enterprises
engaged in dental instruments in China. Over the years, the company has exported about hundreds of types of
products to the United States, product 510K and registration listing of about 50 items.
After both sides signed the cooperation agreement, according to the actual situation of the customer, our company
tailored the consulting programme. In the process of counselling, we carry out one module at a time from training -
procedure revision audit - documentation and record production counselling and audit.
Due to the poor foundation of the client, in order to achieve the goal of passing the audit, we continued to provide
counselling to the client for more than a week beyond the contract period.
The auditor was a South American FDA auditor with 25 years of experience in factory inspection audits and a deep
understanding of Chinese culture. The auditor was very experienced, very clear in his thinking, and knew a little bit
of Chinese. This was a big challenge for the factory audit.
The audit was divided into the following itinerary:
1) CAPA: CAPA cases, feedback, complaints, NCARS
2) Site visit
3) Special process confirmation
4) Design development
5）Supplier file audit
6) DHR and inspection test procedures
7）Production equipment management and maintenance
8）Training and assessment
9）Instrument calibration
10) Document control management
11）Employee interviews
After four days of audit, the factory successfully passed the FDA factory inspection, thanks to the attentive
preparations in the early stage and the timely response and treatment at the site.
After the audit, the FDA auditor highly affirmed the factory and praised the factory for doing a very good job in
process validation, design development and CAPA.
Due to the good cooperation and professionalism during the counselling period, after the audit, the person in
charge of the customer found our colleague and continued to negotiate and signed the next cooperation project:
ISO 13485-2016 version replacement certification.
