IntoCare Medical Triumphs in South Korean FDA Audit with Exceptional Quality Management System, Receives GMP Certification

Author:IntoCare Medical Date:2024-02-27

In the South Korean FDA audit that concluded in January, IntoCare Medical emerged victorious, thanks to its outstanding quality management system. The company underwent a rigorous inspection regarding changes to its production site and passed the audit with flying colors, achieving a 'zero finding' result. This month, the company has been honored with the South Korean GMP (Good Manufacturing Practice) certification, showcasing its expertise and international standard in the medical device manufacturing sector.

The South Korean FDA audit team conducted a comprehensive and meticulous examination of IntoCare Medical's production facilities. The audit covered various aspects including production processes, quality control, equipment, and staff training. Throughout the process, the IntoCare Medical team actively cooperated, demonstrating a high level of professional competence and a meticulous work ethic.

Following the stringent audit, the South Korean FDA highly praised IntoCare Medical's quality management system. The audit team recognized that IntoCare Medical consistently prioritizes patient-centricity and adheres strictly to international medical device production standards, ensuring product quality and safety. This responsible approach and superior quality management set a benchmark for the entire medical device manufacturing industry.

The GMP certificate serves as an international hallmark of a medical device manufacturer's quality management and is a crucial stepping stone for entering the global market. Obtaining this certificate signifies that IntoCare Medical is equipped with internationally aligned medical device production capabilities, laying the foundation to provide high-quality, safe, and reliable medical device products to patients worldwide.

Regarding the success of the audit and the honor received, IntoCare Medical stated that these achievements are the result of the collective effort of all employees and the best testament to the company's unwavering commitment to 'quality first, patient foremost.' In the future, IntoCare Medical will continue to strive to enhance its quality management system, constantly innovate and progress, offering more high-quality and efficient medical products and services to patients globally.

IntoCare Medical's 'zero finding' result in the South Korean FDA audit not only highlights the company's exceptional level of quality management but also establishes a positive image in the international medical device market. With IntoCare Medical's continuous efforts, it is believed that the company will achieve a broader business layout and development on a global scale in the future.


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