Willow Glen Proudly Offers:

$279 FDA Registration & FDA US Agent

Food Facility & Medical Device Establishment 

 

Voluntary Cosmetic Registration Program (VCRP)

 

FDA Certificate of Registration

  • Initial Importer Service for Medical device.

  • FSVP Plan for Food Industry.

  • FSVP Importer and FSVP Agent for foreign supplier.

  • Cosmetic Product Ingredient Statements (CPIS)

 

Useful link:

Willow Glen FDA registration & certification!

Thank you for visiting our website.

Located in the beautiful San Diego County, Willow Glen Consultancy LLC is focused in FDA regulation services. We have 100% commitment — the guiding principles we value and follow each and every day as we work with you toward a successful future.

Our top priority is providing outstanding customer service. We pride ourselves on responding promptly to clients’ needs and providing exceptional individual and business advice and services.

We offer you a level of service that exceeds your expectations, whether you're looking for a facility registration or a complete review of label design.

We thank you for taking time to browse through our site. We hope you find useful information for you here: a list of the services we offer, contact information, specially-selected articles and much more.

Please contact us without hesitation if you have questions. Give us a call or drop us an email for more information about your need, or to make suggestions for what you'd like to see on our website. We look forward to working with you soon!

FDA US Agent (FDA Agent)

Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (FDA US Agent or FDA Agent) for that establishment.

Information about a foreign establishment’s US FDA Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one US FDA Agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the US FDA Agent.

The US FDA Agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the FDA US Agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the US FDA Agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new FDA US Agent to satisfy the regulatory obligation.

Responsibilities of a US FDA Agent

The US FDA Agent must either reside in the US or maintain a place of business in the US. The US FDA Agent cannot use a post office box as an address. The US FDA Agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the US FDA Agent are limited and include:

  • Assisting FDA in communications with the foreign establishment.

  • Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States.

  • Assisting FDA in scheduling inspections of the foreign establishment.

  • If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the US FDA Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.

Willow Glen Consultancy LLC

 Phone: +1-619-869-0249 

 Fax: +1-619-839-0345 

 Info@WillowGlenFDA.com

 3755 Avocado Blvd, Suite 208
 La Mesa, CA 91941, USA

Line ID: WillowGlenFDA

WeChat ID:

WillowGlenFDA

WhatsApp:

+1-619-869-0249