Food Facility FDA Registration
Food facility registration is a mandatory safety requirement. This process is not a one-time "certification," but a continuous commitment to compliance. Without a valid registration number, shipments are subject to immediate detention at the port of entry, which can lead to significant financial losses and damage to your brand's reputation with U.S. buyers. By registering, your facility acknowledges its responsibility to meet U.S. safety standards and grants the FDA the authority to conduct inspections.
When you partner with a professional service for your FDA registration, you receive a full-cycle compliance solution. Based on industry standards, our comprehensive package includes:
- UFI/DUNS Number Assistance: We help you obtain or verify your Unique Facility Identifier (DUNS), a prerequisite for all new and renewing registrations.
- Form 3537 Submission: We manage the precise preparation and electronic filing of FDA Form 3537, ensuring all facility details, trade names, and parent company information are accurate.
- Mandatory U.S. Agent Designation: For foreign facilities, we provide the legally required U.S. Agent representation, serving as your 24/7 liaison for official FDA communications and emergency alerts.
- Product Category Mapping: We ensure your facility is correctly registered under the appropriate FDA food product categories and activity type.
- Biennial Renewal Management: We automatically track your mandatory biennial renewals (required every even-numbered year between Oct 1 and Dec 31) to prevent registration expiration.
- FDA Communication & Inquiries: Our team handles routine regulatory questions from the FDA and assists in coordinating site inspection schedules.
- Registration Verification & Updates: We provide official confirmation of your registration number and update your profile whenever there are changes in ownership, management, or physical address.