Congratulations to Shenzhen Jingkehui Electronics for passing the US FDA factory inspection
Source: Success cases Edit: Reanny Medical Devices Management Consulting Co., Ltd. Read: 361 Date: 2024-06-18
Shenzhen Jingkehui is a specialized manufacturer of OTC electrical stimulators, which includes design, manufacturing, and sales processes. North America is the main market for customers, and FDA factory audits are crucial for them.
Due to the successful cooperation experience with CE in the early stage, the customer did not hesitate to deliver the coaching contract for FDA factory inspection to our company.
After initiating the coaching, our company provided a lot of support in training, program modification, record coaching, case analysis and support, and difficult point tackling, enabling the client to complete all the audit preparation work before the audit.
The auditor who came to audit is an African American auditor from the United States, who works very seriously and has a very clean character.
Through the full cooperation of both parties, the 4-day review was successfully passed.
During the coaching and review process, both parties further consolidated their trust in cooperation, laying a solid foundation for long-term annual services in the future.