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FDA Registration

We’re here to assist you if you’re unable to locate the information you need. Just fill out our easy form to inquire about FDA Compliance & Procedures, and we’ll gladly provide you with the information you seek. We’re looking forward to helping you. Gitchia Group LLC helps companies across all FDA-regulated industries comply with FDA registration regulations quickly and properly. Gitchia Group LLC can help your facility register with FDA and much more.

FDA Registration and Renewal

FDA-registered food facilities are required to register with FDA and renew their registration every other year on December on even-numbered years.

DUNS Assistance 

All facilities /establishments and food facilities are now required to submit Unique Facility Identifiers (UFIs) as part of their initial FDA registration as well as their registration renewal. Currently, the only UFI recognized by FDA is the DUNS number.

NEW IN 2022: All registered food facilities must include their DUNS number in their registration renewal for the October-December 2022 renewal period.  

U.S. Agent

All registered food facilities located outside of the U.S. must designate a U.S. Agent, a representative located in the U.S. who is available 24 hours a day to answer FDA’s questions about your company’s shipments and assist in organizing food facility inspections.

Prior Notice 

FDA requires the filing of Prior Notice for all food, beverage, and dietary supplements shipments entering the United States. Prior Notice submissions must contain certain pieces of information, including a valid FDA registration number. 

Mock FDA Inspection

FDA may choose to conduct a routine inspection of any registered food facility based on a number of factors. Gitchia Group LLC can dispatch a Food Safety Specialist to help your facility prepare for an FDA inspection. We offer these to our existing clients at a reduced rate.

Certificate of Registration: Certificates issued by Gitchia Group LLC provide confirmation of your facility’s registration.

Registration Updates: Registrations must be updated within 60 days of a change in required information

Prior Notice: Three free Prior Notice filings each year for your exports to the USA

FDA Compliance Monitoring: A unique system that continuously monitors your company’s FDA compliance status   

Compliance Document Management: Store and share your required FDA Compliance Documents, such as Food Safety Documentation, GFSI Certifications, Product Labels, and more  

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FDA Inquiry Form

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