Food and Drug Administration (FDA) established in 1906 is a government agency under the passage of the Federal Food and Drugs Act. It is the oldest comprehensive agency for consumer protection. The FDA Certification is mandatory for placing the products in the USA.
It is an agency which is part of the United States Department of Health and Human Services. This major responsibility of FDA is protecting and managing public health and related authorities by assuring the safety and security of human and biologically generated product. The FDA regulates products including biological products, medical services, cosmetics, prescription drugs and non-prescription drugs, veterinary drugs, tobacco and other radiation emitting products.
FDA issues form 483 for FDA Certification of the products after the inspection by an official of FDA. As per FDA guidelines, the food and drug plants in India should adhere to Current Good Manufacturing Practices (CGMP). FDA helps to ensure the safety, quality, and effectiveness of medical and food products produced in India for export to the United States.