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Section 12 INSPECTION STATEMENT FDA will be permitted to inspect the facility at the time and in the manner permitted by the Federal Food Drug and Cosmetic Act. INDIVIDUAL AUTHORIZED TO SUBMIT THE REGISTRATION FILL IN BELOW If you checked Box B above indicate who authorized you to submit the registration. NAME OF INDIVIDUAL WHO AUTHORIZED REGISTRATION ON BEHALF OF OWNER OPERATOR OR AGENT IN CHARGE FILL IN ADDRESS BELOW Address Information for the Authorizing Individual Authorizing Individual S ...

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What is the cost of FDA registration?

The FDA annual registration fee for each establishment is $5,672 (in United States dollars) up from the $5546 of 2021. As previously, there are no waivers or reductions for small establishments, businesses, or groups. The annual establishment registration fee must be paid between October 1, 2021, and December 31, 2021.

Who needs FDA food facility registration?

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FDC Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional

Who is required to register with FDA?

Food. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Who needs FDA food facility registration?

Food Facility Registration Requirement Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in 21 CFR 1.227, for human or animal consumption in the United States must register with FDA.

What is an FDA approved facility?

This means that a company must demonstrate that its drug or biological product is safe and effective for the intended use, and that it can manufacture the product to federal quality standards.

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