What is USA FDA Food Registration?
USA 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 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 it for the first time.
Benefits of USA FDA Food Registration
Reduced risk
Reputation
Access to new business
Improved efficiency
Customer satisfaction
Helps you stand out from your competitors
Certified USA FDA Food Video
Who can be certified USA FDA Food Registration?
Baked goods
Beverages
Biscuits
Breakfast foods
Cakes
Canned (tinned) foods
Chips, crisps, corn snacks, nuts and seeds
Condiments
Dairy products
Egg products
Frozen foods
Meats
Merchant Exporter
Document required for USA FDA Food Registration
- Technical File, Product Master File (TCF)
- Product Testing
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Plant Master File
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Product and it's uses
- Testing requirement of products
- Directive in which product classified
- Self Certification or Compliance Certification
- Notify body Certificate
Role of Shamkris and Process of USA FDA Food Registration
Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.
The implementation process is described below:
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 & 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.
Time Frame
Step 1 to Step 6
• It takes 2 weeks to done process
Step 7
FDA Food Registration Renewal
• Support for Renewal before 31st December every year.
FAQ
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.
Food and Drug Administration never approve or disapprove any US Agent organization.
https://www.grants.gov/applicants/organization-registration/step-1-obtain-duns-number.html
https://www.dnb.com/duns-number/get-a-duns.html
https://fedgov.dnb.com/webform/
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.
If the exporter stores food at the facility, the same facility also must register with FDA. If you just invoice and the manufacturer sends it to the destination, your facility need NOT register.
NO. The FDA Food Facility Registration number is confidential. You need to mention it only at the time of sending a prior notice.