Dongguan WELLPOWER Sports Equipment Co., Ltd. is a well-known Taiwanese enterprise with factories in Liaobu, Dongguan and Ganzhou, Jiangxi, employing over 5000 people.
The company mainly produces various sports equipment on behalf of international top sports brands such as Nike, Adidas, and Cardinon. In order to expand the company's new profit pivot, the company has launched the design and production of medical corrective equipment, elastic socks and other medical devices.
To ensure compliance with the requirements of QSR 820 in the United States and obtain orders from American pharmaceutical chain giants. The company proactively applied for a third-party audit in accordance with the requirements of US GMP.
Under effective organization, implementation, and guidance in the early stage, a three-day GMP audit was passed.
The audit process follows the requirements of QSIT in the United States, including design and development, management responsibilities, production processes CAPA、 Detailed audits were conducted on the instrument and equipment, document management, and procurement management modules.
After the audit, the result was very satisfactory and appreciated by the auditor.
