返回WELLPOWER is a well-known Taiwanese company with factories in Liao Bu, Dongguan and Ganzhou, Jiangxi Province,
employing about 5,000 people.
The company mainly produces OEM sports equipment for NIKE, Adidas and Cardinon. In order to expand the
company's profitability, the company has initiated the design and production of medical devices such as medical
orthopaedic appliances and compression stockings.
In order to ensure compliance with the US QSR 820 requirements, the company obtained orders from US
pharmaceutical chain giants. The company took the initiative to apply for a third party to conduct an audit according
to the requirements of U.S. GMP.
Through the effective organisation, implementation and guidance in the early stage, the company passed the
three-day GMP audit.
The audit process was in accordance with the requirements of the U.S. QSIT, and the design and development,
management responsibilities, production process, CAPA, instrumentation, document management, and procurement
management modules were audited in detail.
After the audit, the results of the audit were very satisfactory and appreciated by the auditor.
