FDA Registration from jobinwason's blog

What is FDA?

The Food and Drug Administration (FDA), stands for an agency in the US designated to ensure the safety of a wide variety of consumer products. This regulatory agency, established under the Federal Food and Drugs Act of 1906, has a fairly wide scope in different industries, such as:

·         Food and beverages

·         Cosmetics

·         Drugs and/or pharmaceuticals

·         Medical devices

·         Vaccines

·         Household hazardous products

·         Pesticides

FDA Registration: Necessity and Cost

Generally, an organization or its products involved in any of the following activities in United States for the above listed product categories requires FDA registration annually.

·         Importing

·         Exporting

·         Wholesale trading

·         Distribution

·         Manufacturing

Annual FDA Registration Fee is around $5,546. There are no renunciations or reductions for small organizations, businesses, or groups – all institutions have to pay the registration fee to FDA.

General procedure followed in FDA registration

FDA certificate registration is done through Centre for Food in the FDA central office. The Licence to Operate (LTO) is, at first, valid for one year.  After renewal, the LTOs will be valid for two years. The following document is minimum required for FDA registration:

·         A notarized petition-form

·         Certificate of Attendance to a seminar on licensing of establishments sponsored by FDA.

·         Proof of business registration

·         Proof of occupancy or business address to be given

·         Documents about the business location itself including a floor plan with dimensions. Visit FDA Registration in UK

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