Congratulations to Dongguan Jiate Medical Equipment Company for passing the FDA factory inspection

Dongguan Jiate Medical Equipment is a professional manufacturer of various disposable dental consumables, and is a subsidiary factory of Wanlian International Co., Ltd.

The company was founded in 2002 and has multiple production workshops including injection molding, extrusion molding, tube drawing, blown film, masks, hair sticks, and automatic assembly. It is one of the earliest enterprises engaged in dental instruments in China. Over the years, the company has exported over a hundred types of products to the United States, with a total of 510K products and more than 50 registered items.

After signing the cooperation agreement, our company tailored a consulting plan based on the actual situation of the client. In the process of coaching, we conduct training, program revision review, document and record creation coaching and review module by module.
Due to the poor foundation of the client, in order to achieve the goal of approval, we have exceeded the contract period by more than a week to continue providing coaching to the client.

The auditor is a South American FDA auditor with 25 years of experience in factory inspection and auditing, and a deep understanding of Chinese culture. The auditor has extensive experience, clear review thinking, and a basic understanding of Chinese. This is a significant challenge for factory audits.
The audit is divided into the following itinerary:
1) CAPA: CAPA cases, feedback, complaints NCARS
2) On site inspection
3) Special Process Confirmation
4) Design and development
5) Supplier file review
6) DHR and Inspection Test Procedure
7) Production equipment management and maintenance
8) Training and Assessment
9) Instrument calibration
10) Document control management
11) Employee interviews

With careful preparation in the early stage and timely response and handling on site, the factory passed the FDA factory inspection smoothly after a four-day audit.
After the audit, the FDA auditor highly praised the factory for its excellent performance in process validation, design and development, and CAPA.

Due to the good cooperation and professional spirit during the coaching period, after the audit was completed, the client's responsible person approached our colleagues and continued to negotiate and sign the next cooperation project: ISO 13485-2016 version certification.