America Product Certification
FDA
The U.S. Federal Food and Drug Administration (FDA) is one of the U.S. Department of Health and Human Service's oldest and most trusted consumer protection agencies. In Korea, it is the Ministry of Food and Drug Safety. When foreign companies export to the United States, products from US customs are often detained (seized) due to unfamiliarity with FDA regulations, of which food, cosmetics and medical devices account for most.
FDA Role
The most important role of the FDA is to protect public health by managing the safety and efficient production, distribution, and sales of various products, and to continuously monitor the safety of products even while consumers are using them.
FDA Investigation
FDA's investigation, analysis, research, and regulatory compliance monitoring are under the jurisdiction of the National Medical Device and Radiation Protection Center, the Biology and Research Center, the Drug Evaluation and Research Center, the Food Safety and Nutrition Center, and the Veterinary Medicine Center.
FDA Enforcement Rules
FDA performs three main tasks: analysis, surveillance, and assessment. Analysis is a task to take precautions that can be taken during customs clearance before a new product is shipped to the US market, and the monitoring task is to inspect the production plant and facilities of the product, and is performed by front-line inspectors. It is an institution that can take stronger sanctions against regulatory violations such as mixing of impurities or false labeling.
FDA Enforcement Rules
· FDA Food Standards
Detailed regulations for food and these products.
· Good Manufacturing Practices (CGMP)
Quality control guidelines such as hygiene, inspection, and regulations for the design, manufacture and sale of food and products.
· New Drug Regulation
Regulations on approval of new drugs and on the continued safety and efficacy of drugs
Business License 107-81-76722
Address (08504) Room 501, #638, Seobusaet-gil, Geumcheon-gu, Seoul, Republic of Korea
Tel. 02-6749-0701 | FAX 02-6749-0711 | E-MAIL info@igcert.org
Business hours AM 09:00 ~ PM 06:00 (※ Closed on weekends and holidays.)
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