FDA Facility Registration & U.S. Agent Representation Services

All the experience and advice for the success of your business in the USA

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U.S. Agency, Registration and Listing

Do not take unnecessary risks, for a fair price take advantage of a service of processing and serious representation before the FDA

New FDA Facility Registration

We take care of registering with the FDA and obtain your first certificate.

Renew a Facility Registration

We comply with the regulations in force, carrying out the processes of renewing records, in the deadlines and forms provided by the authorities, avoiding our customers risks or even loss or cancellation of their records.

Modify or Cancel a Registration

The authority requires that any change regarding the information delivered to the FDA in its registration process must be updated within the timeframes provided, in the same way if its operations cease it is obliged to request the termination of the registration.

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US Agent and Representation

Now it is simple to have an agent that meets the requirements of the FDA. Do not hesitate and call us.

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How its works

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.

To carry out certain provisions of the Bioterrorism Act, FDA established regulations requiring that:

  • Food facilities register with FDA, and
  • FDA be given advance notice on shipments of imported food.

These regulations became effective on December 12, 2003.

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. Specifically, if FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:

  1. Created, caused, or was otherwise responsible for such reasonable probability; or
  2. Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food. 
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AndesBureau

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Miami, FL 33186
+1 (786) 358-0110
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CHILE BRANCH

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Oficina 309, Providencia
Santiago 7500505
+56 (2) 3210-3840
info@andesbureau.cl

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