Kolmar B&H acquires a rating of 'flawless NAI' at the U.S. FDA's Sejong and Eumseong plant site survey
Sep 23, 2024
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The on-site inspection was conducted in July 6 at the Kolmar B&H Sejong plant and Eumseong plant, which are manufacturing facilities for U.S. exports, and strict inspection of the manufacturing process of major items such as dietary supplements and powder sticks. The U.S. FDA's due diligence showed that Colmar B&H's quality control and safety system met the highest global standards, further strengthening international trust.
Kolmar B&H currently produces various health functional foods such as fatigue recovery, joint health, and blood flow improvement, as well as immune function and fatigue improvement products 'hemohim', and supplies more than 1,000 health functional foods to more than 300 customers in 26 countries around the world. As of the first half of this year, the proportion of overseas sales is about 40%, and the proportion of overseas sales is expected to increase further by expanding exports based on various global certifications including FDA certification.
In 2021, Kolmar B&H obtained GMP (Good Manufacturing Standards) certification from the Australian Federal Drug Administration (TGA), Australia's pharmaceutical and health functional food management and supervision agency, for the manufacture of liquid health functional food at the Sejong plant, and last year, it obtained additional Australian GMP certification up to the Eumseong plant. In addition, it has various overseas certifications such as Halal, FSSC22000, and ISO 14001.
"The U.S. FDA review is an important criterion for ensuring the safety and effectiveness of products through thorough and systematic procedures, and the acquisition of FDA zero-defect rating is an important achievement for Kolmar B&H in recognition of its quality in the global market. We will continue to strengthen our competitiveness in the global market through continuous quality innovation and global certification to establish ourselves as a more trusted partner for our domestic and foreign customers."
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