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
Step by Step Process for FDA Food Facility Registration
Step 1: Appoint FDA Regulatory Expert & US Agent
Step 2: DUNS Request
Step 3: Fill online Application and US Agent appointment Authorization
Step 4: Submit Application for FDA Registration
Step 5: Allocation of FDA 11 Digit Food Facility Registration Number.
Step 6: Receipt of Registration Certificate from US Agent
- 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
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?
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?
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?
Is DUNS number mandatory for Food Facility Registration?
Customers can find more information from below websites.