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    Guidance on Food Contact Substance including Testing

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    FDA Food Facility Registration & Renewal

    FDA Food Facility registration is simple, but it is tiring and confusing for those doing for the first time. We provide food facility registration from India & other Asia Pacific countries. You can contact our customer care number +91 9945 91 2081. Customers can use the facility on all working days for technical support in FDA establishment registration, Label Review & US Agent Service .

     

    USA Food Regulatory Agency of the Department of Health and Human Services have taken steps to protect the public from the food supply and related emergencies by enforcing the Bioterrorism Act from December 12, 2003.

    • Must submit establishment registration information, with consent to inspect the facility at any time as per the FDA protocol
    • Must renew food facility registrations every other year, with consent to suspend registration if found reasonable cause as per the protocol
    • Each food facility should have its own 11-digit registration number. If the same management has multiple facilities for manufacture and export to the USA, each of the facilities is required to register and obtain different food facility 11-digit registration numbers

    We are FDA Regulatory Experts and US Agent!

     

    We do FDA Food Facility Registration FREE of cost to all customers across the Globe who appoint us as there FDA US Agent. The reason; majority of cases, customers would make simple mistakes during online registration and can land up in critical and complex situations when the food items reach the US port of entry.

    Step by Step Process for FDA Food Facility Registration

    Step 1: Appoint FDA Regulatory Expert & US Agent

    All foreign facilities engaged in the manufacturing, Repacking, Relabeling & Warehousing  of food items used for consumption in United States must appoint US Agent.

    Step 2: DUNS Request

    All foreign Food facilities planning to register with FDA must furnish the Data Universal Numbering System (DUNS) .

    Step 3: Fill online Application and US Agent appointment Authorization

    It is mandatory to submit online application and appoint US Agent before proceeding with FDA application.

    Step 4: Submit Application for FDA Registration

    We, the regulatory experts / US Agent will apply for Registration on all working days.

    Step 5: Allocation of FDA 11 Digit Food Facility Registration Number.

    On receipt of application FDA will generally issue number soon. The registration number will be forwarded to registered mail ID only.

    Step 6: Receipt of Registration Certificate from US Agent

    US Agent will issue registration Certificate as a proof to show potential customers and shipping companies. Food facility registration details are kept confidential by FDA.
    Food Facility Registration Fees & Timeline

    • Annual US Agent Fees : 349 USD
    • 15 minutes consultation with an expert : 249 USD

     

    US FDA Food Facility Registration Timeline : less than 12 hours on working days.

    New DUNS request may take 7-14 working days 

    US Agent Authorization & Application Form
    US Agent Authorization & Application Form

    Quick & Simple Form with Payment option

    Fill the Form
    Food Facility Registration Renewal

    Food Facility Registration and renewal was mandated by FSMA from the year 2011. Both foreign and domestic facilities engaged with the processing of food, beverages, nutraceuticals must renew their existing FDA food facility registration.

     

    The renewal is important for the FDA to keep their records up-to-date. All Foreign FDA Registered food facilities must contact their US Agent and authorize to complete its renewal process.

     

    It is important to note that the FDA will cancel registrations that are not renewed by 31st December of the biannual period. All food exported to the US port will be kept on hold and will not be released to the importer, owner, or consignee until the facility is re-registered with new 11-digit registration number

    Frequently Asked Questions

    Do I need to keep the FDA Food Establishment registration number in all communications and invoice?

    NO. The FDA Food Facility Registration number is confidential.  You need to mention it only at the time of sending a prior notice.

    I am planning to export food to the USA. I own the brand but manufactured from a different facility. Which Food facility I should need to register?

    The MANUFACTURER  / Manufacturing Facility must register with FDA.

    If exporter store food at facility, the same facility also must register with FDA. If you just invoice and the manufacturer sends to the destination, your facility need NOT register.

    Is it compulsory to register with the FDA for all food manufacturers to sell in the USA market?

    Yes, the manufacturer registration is a must! In case of any food quality issues, the FDA will conduct an ONSITE audit as per 21 CFR 110 or 21 CFR 111.

    Is DUNS number mandatory for Food Facility Registration?

    Yes. Data Universal Number System (DUNS) mandatory from 1st October 2020.

    Customers can find more information from below websites.

    1. https://www.grants.gov/applicants/organization-registration/step-1-obtain-duns-number.html
    2. https://www.dnb.com/duns-number/get-a-duns.html
    3. https://fedgov.dnb.com/webform/

    Is your US Agent Firm approved by the FDA?

    Food and Drug Administration never approve or disapprove any US Agent organization.

    I am a merchant exporter planning to export food items to USA. Do I need to register?

    If you only invoice from your location and items shipped directly to the destination by the original manufacturer, then your facility need NOT to be registered with the FDA.