The U.S. Food and Drug Administration (FDA) requires all domestic and foreign food facilities that manufacture, process, pack, or store food for consumption in the United States to be registered with the FDA.
This registration is a critical compliance requirement under the Food Safety Modernisation Act (FSMA), helping the FDA maintain oversight and ensure food safety. By registering, food facilities are granted authorisation to operate and distribute food products in the U.S. market.
Key Components of FDA Registration
- Mandatory Requirement for U.S. Market Access:
FDA registration is required for all food facilities (both domestic and international) that intend to distribute products in the United States. - Renewal Process:
Registration must be renewed every two years during the period between October 1 and December 31 of each even-numbered year. Failure to renew the registration can result in suspension. - Unique Facility Identification Number (UFI):
As part of the registration process, facilities must provide a UFI, such as a Data Universal Numbering System (DUNS) number, to uniquely identify the facility. - Compliance with FDA Regulations:
Registered facilities must comply with all relevant FDA food safety regulations, including Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), and preventive controls required by FSMA. - Inspection and Enforcement:
Registered facilities are subject to FDA inspections to ensure compliance with food safety regulations. Non-compliance can result in facility shutdowns or product recalls.
Project Timeline
The FDA registration process typically takes two to four weeks, depending on the readiness of the facility and the availability of required documentation. Renewal and ongoing compliance services are continuous and aligned with the FDA’s bi-annual renewal cycle.
Why Choose TotalCert Consulting FDA Registration ?
FDA Compliance Expertise
Our consultants are experts in FDA regulatory requirements and food safety, ensuring that your facility achieves and maintains compliance efficiently.
End-to-End Support
From initial registration to renewal and ongoing compliance, we provide comprehensive services to keep your facility operating smoothly in the U.S. market.
Tailored Solutions
We customise our services to meet the specific needs of your food facility, ensuring that you meet all FDA registration requirements and maintain compliance with ease.