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BOLETIN INFORMATIVO 17021700

Ultimas Regulaciones para Agentes en USA ante la FDA

1 Ingles a continuación Castellano

In accordance with 21 CFR 1.231(a)(5) and (b)(7), FDA will not confirm a registration or provide a registration number until the person identified as the U.S. agent for a foreign facility confirms that person has agreed to serve as the U.S. Agent. We are requesting your action within 30 calendar days of receipt of this notification. If you take no action within 30 calendar days, the registration information will be removed from our database and the facility will be required to submit another registration submission.

To confirm or decline this listing, please click on the following link and provide the above listed receipt code when prompted: https://www.access.fda.gov/.

If you confirm this listing, you will assume the responsibilities of the U.S Agent and the registrant will receive their registration number. Please note that you will need to save the above listed receipt code to maintain access to this registration in the future.

If you decline this listing, the registrant will be notified that you have not agreed to serve as the U.S. Agent for the facility. We will then request that the facility amend its registration to designate another U.S. Agent who has affirmatively agreed to serve.

If you confirm this listing as the U.S. Agent for the foreign food facility listed above, but your contact information is incorrect, the owner, operator, or agent in charge of the facility or an individual authorized by the owner, operator, or agent in charge of the facility must update this information within 60 calendar days of any change to the previously submitted contact information using Form FDA 3537. The authorized individual may be, but is not required to be, the U.S. Agent for the facility. When using Form FDA 3537, the owner, operator, or agent in charge, or the individual authorized by one of them, must check the items being updated in Section 1 of the form. If the facility has an existing electronic account (established when the facility is registered electronically) that is linked to this registration, the registration may be updated electronically via https://www.access.fda.gov/.

Alternatively, the owner, operator, or agent in charge of the facility, or an individual authorized by one of

them, may submit an update by mail or fax to:

U.S. Food and Drug Administration 5001 Campus Drive, HFS-681

  College Park, MD USA 20740 Fax: 301-436-2804

Section 743 of the FD&C Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the facility.

You may contact the FDA Industry Systems Help Desk via telephone at 1-800-216-7331 or 301-575-0156 if you have any questions about this process.

Thank You.

FDA Unified Registration and Listing and Prior Notice System Helpdesk.

In accordance with 21 CFR 1.231(a)(5) and (b)(7), FDA will not confirm a registration or provide a registration number until the person identified as the U.S. agent for a foreign facility confirms that person has agreed to serve as the U.S. Agent. We are requesting your action within 30 calendar days of receipt of this notification. If you take no action within 30 calendar days, the registration information will be removed from our database and the facility will be required to submit another registration submission.

To confirm or decline this listing, please click on the following link and provide the above listed receipt code when prompted: https://www.access.fda.gov/.

If you confirm this listing, you will assume the responsibilities of the U.S Agent and the registrant will receive their registration number. Please note that you will need to save the above listed receipt code to maintain access to this registration in the future.

If you decline this listing, the registrant will be notified that you have not agreed to serve as the

U.S. Agent for the facility. We will then request that the facility amend its registration to designate another U.S. Agent who has affirmatively agreed to serve.

If you confirm this listing as the U.S. Agent for the foreign food facility listed above, but your contact information is incorrect, the owner, operator, or agent in charge of the facility or an individual authorized by the owner, operator, or agent in charge of the facility must update this information  within  60  calendar  days  of  any  change  to  the  previously  submitted  contact

information using Form FDA 3537. The authorized individual may be, but is not required to be, the

U.S. Agent for the facility. When using Form FDA 3537, the owner, operator, or agent in charge, or the individual authorized by one of them, must check the items being updated in Section 1 of the form. If the facility has an existing electronic account (established when the facility is registered electronically) that is linked to this registration, the registration may be updated electronically via https://www.access.fda.gov/

Alternatively, the owner, operator, or agent in charge of the facility, or an individual authorized by one of them, may submit an update by mail or fax to:.

U.S. Food and Drug Administration

5001 Campus Drive, HFS-681

College Park, MD USA 20740

Fax: 301-436-2804

Castellano

De acuerdo con 21 CFR 1.231 (a) (5) y (b) (7), la FDA no confirmará un registro o proporcionará un número de registro hasta que la persona identificada como el agente de EE.UU. para una instalación extranjera confirme que esa persona ha aceptado servir Como el agente de los EEUU. Solicitamos su acción dentro de los 30 días calendario posteriores a la recepción de esta notificación. Si no toma ninguna acción dentro de los 30 días calendario, la información de registro será eliminada de nuestra base de datos y la instalación deberá enviar otra solicitud de registro.

Para confirmar o rechazar este listado, haga clic en el siguiente enlace y proporcione el código de recibo  arriba indicado cuando se le solicite: https://www.access.fda.gov/.

Si confirma este listado, asumirá las responsabilidades del Agente de los Estados Unidos y el registrante recibirá su número de registro. Tenga en cuenta que tendrá que guardar el código de recibo indicado anteriormente para mantener el acceso a este registro en el futuro.

Si rechaza este listado, se le notificará al registrante que no ha aceptado servir como el Agente de los Estados Unidos para la instalación. A continuación, solicitaremos que el establecimiento modifique su registro para designar a otro Agente de los Estados Unidos que haya aceptado de manera afirmativa servir.

Si confirma este listado como el Agente de EE.UU. para el establecimiento de alimentos extranjero mencionado anteriormente, pero su información de contacto es incorrecta, el propietario, operador o agente a cargo de la instalación o una persona autorizada por el propietario, operador o agente a cargo De la instalación debe actualizar esta información en un plazo de 60 días calendario después de cualquier cambio en la información de contacto presentada anteriormente usando el Formulario FDA 3537. La persona autorizada puede ser, pero no está obligada a ser, el Agente de EE.UU. para la instalación. Cuando use el Formulario FDA 3537, el propietario, operador o agente a cargo, o la persona autorizada por uno de ellos,  debe comprobar los elementos que se están actualizando en la Sección 1 del formulario. Si la instalación tiene   una

cuenta electrónica existente (establecida cuando la instalación está registrada electrónicamente) vinculada a este registro, la inscripción puede actualizarse electrónicamente a través de https://www.access.fda.gov/.

Alternativamente, el dueño, operador o agente a cargo de la instalación, o una persona autorizada por uno de ellos, puede enviar una actualización por correo o fax a:

Administración de Alimentos y Medicamentos de los Estados Unidos

5001 Campus Drive, HFS-681

College Park, MD Estados Unidos 20740

Fax: 301-436-2804

Sección 743 de la Ley FD & C [21 U.S.C. 379j-31] autoriza a la FDA a evaluar y cobrar tarifas para cubrir los costos de la FDA para ciertas actividades, incluyendo los costos relacionados con la reinspección. Una reinspección es una o más inspecciones realizadas después de una inspección que identificó el incumplimiento materialmente relacionado con un requisito de seguridad alimentaria de la Ley FD & C, específicamente para determinar si se ha logrado el cumplimiento. Los  costos  relacionados con la reinspección significan todos los gastos, incluidos los gastos administrativos, incurridos en la realización y la evaluación de los resultados de la reinspección y la evaluación y la recaudación de los honorarios de reinspección [21 U.S.C. 379j-31 (a)  (2) (B)]. Para una instalación extranjera, la FDA evaluará y cobrará honorarios por los costos relacionados con la reinspección del Agente de los Estados Unidos para la instalación.

Puede ponerse en contacto con el Centro de Ayuda de Sistemas Industriales de la FDA por teléfono al 1-800- 216-7331 o 301-575-0156 si tiene alguna pregunta sobre este proceso.

Gracias.

FDA Unified Registration and Listing y Sistema de Notificaciones Previas Helpdesk.

Atentamente

Pablo A. Salazar Director

Food Technologies Services

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