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FDA Food Facility Registration

FDA Food Facility Registration from India office.  Contact customer  care number +91 9945912081. Customers can use the facility on all working days for US FDA establishment registration, Label Review, US Agent Service etc.

 

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
  • FDA Food Facility registration is simple, but it is tiring and confusing for those doing for the first time.

We are the FDA Regulatory Experts and US Agent!

 

Annual US Agent fees is only $ 349.  We do FDA Food Facility Registration FREE of cost! In 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

Appoint FDA US Agent

All foreign facilities engaged in the manufacturing, warehousing  and or repacking of food items used for consumption in United States must appoint US FDA Agent.

 

After appointment we complete the food facility registration and issue our registartion certificate as of proof of successful completion.

 

It is important to note that FDA will cancel registrations that are not renewed by 31st December of the biannual period. All food exported to US port will be kept hold and will not be released to the

Submit Online Application Form

Domestic and Foreign manufactures must submit online application form provided below.

Customers can make the payment online.

Isssue of 11 Digit Registration number by FDA

Soon after completion of Food establishment registration FDA will issue the 11 digit registration number to registered  email.

Issue of Registration Certificate

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.

Check before you export Food & Supplements to the USA!

  • Is the MANUFACTURER of food items registered with the FDA and has held a valid 11-digit registration number?
  • Is the EXPORTER (with WAREHOUSE) of food items registered with the FDA and has held a valid 11-digit registration number?
  • Is the EXPORTER & RE-LABELER/RE-PACKER registered with the FDA and has held a valid 11-digit registration number?
  • Is the IMPORTER in the USA registered with the FDA and has held a valid 11-digit registration number?
  • Is the EXPORTER of food appointed an independent US FDA Agent for your facility?
  • Whether the FDA Agent accepted and confirmed the FDA quire on the appointment?

FDA Food Facility Registration Renewal

FDA registration 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

Is your US Agent Firm approved by the FDA?

NO. US FDA will not approve or disapprove any organization from acting as US Agent.

I am a merchend exporter of food items. Do I need to register?

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

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 of the FOOD must register.

If you store goods at your facility, you must also register. 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.

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

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