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US FDA Food Facility Registration
FDA Food facility registration is simple, but it is tiring and confusing for those doing it for the first time. We provide food facilities registration from India and other Asia-Pacific countries. Customers can use the facility on all working days for technical support in registration, label review, and FDA Agent service.
The US Food Regulatory Agency of the Department of Health and Human Services has taken steps to protect the public from the food supply and related emergencies by enforcing the Bioterrorism Act as of December 12, 2003.
Some food facilities are exempt from registration, they are Farms, Retail food establishments, Restaurants, Nonprofit food establishments, Fishing vessels not engaged in processing, Facilities that only store packaged food that is not exposed to the environment
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FDA Food Facility Registration Requirements
To register your food facility with the US FDA, you’ll need to provide information about your facility, the facility contact person and the activities it conducts. By providing accurate and up-to-date information, you help the FDA to quickly identify and locate food facilities during inspections, recalls, and emergencies. The below facilities are permitted to do food establishment registration
- If your facility is involved in Food Manufacturing
- If your facility processes food
- If your facility packs food
- If your facility holds food
Additional Information:
- Must submit establishment registration information, with consent to inspect the facility at any time as per the FDA protocol.
- Must renew FDA food facility registration every other year, with consent to suspend registration if found reasonable cause as per the protocol.
- Each facility should have its own 11-digit FDA food facility 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 FDA facility registration number.
Guide to the Basics of Food Facility Registration
We do FDA food facility registration free of charge for all customers across the globe who appoint us as their US FDA Agent. The reason is that, in the majority of cases, customers make simple mistakes during online registration and can land in critical and complex situations when the food items reach the US port of entry.
Step 1: Appoint FDA Regulatory Expert & US FDA 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
To begin the FDA food facility registration process, you’ll need to provide your facility’s DUNS number and owner information. You can start the registration process by following the link provided on the right side and uploading the necessary information. If you need further assistance, feel free to contact us!
Food Establishment Registration Fees & Timeline
We are more than just a US Agent. We are Good Manufacturing Practice (GMP) experts specializing in food, food supplements / Neutraceuticals, as well as proficient auditors. Our annual fees are the most competitive in the industry, surpassing even those of other US Agents and GMP experts. Below, you will find fee and timelien:
- Annual US Agent Fees: 349 USD
- A 15-minute consultation with an expert: 249 USD
- FDA Food Facility Registration Timeline: less than 12 hours on working days.
- New DUNS request may take 7-14 working days
US FDA Food Facility Registration Renewal
FDA 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 Facility registration number in all communications and invoice?
No. The US 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?
If the exporter stores food at a facility, the same facility also must register with the US FDA. If you just invoice and the manufacturer sends it 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 FDA Food Facility Registration?
Customers can find more information from below websites.
Is your US Agent Firm approved by the US FDA?
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 needs NOT to be registered with the US FDA.