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Food Facility Registration

FDA Food Facility Registration in Minutes, Not Hours

12 minutes with CaseMark

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Run it in CaseMark

Upload your documents and get a finished work product in minutes. New accounts get $5 free to run their first skill.

12 minutes with CaseMark

What you'll need

  • Facility Information
  • Parent Company Details
  • Food Product Categories

SOC 2 Type II · HIPAA compliant · $5 free credit

Workflow

Overview

Preparing FDA food facility registration documents manually requires navigating complex regulatory requirements, gathering information across multiple departments, and ensuring precise compliance with federal food safety laws. Attorneys and compliance professionals spend hours cross-referencing regulations, formatting documents correctly, and verifying that all mandatory fields meet FDA specifications.

Food facility registration under 21 CFR Part 1 requires extensive documentation, precise regulatory language, and careful attention to FDA requirements. Manual preparation is time-consuming, error-prone, and requires deep knowledge of Bioterrorism Act compliance, product categorization codes, and biennial renewal obligations.

CaseMark automates the entire FDA food facility registration process, generating compliant documentation that meets all Federal Food, Drug, and Cosmetic Act requirements. Our AI ensures accurate facility information, proper US agent designation, complete product categorization, and legally sound certification statements ready for FURLS submission.

How it works

  1. 1. Upload your documents

  2. 2. AI analyzes and extracts key information

  3. 3. Review and customize the generated content

  4. 4. Export in your preferred format (DOCX, PDF)

What you get

  • Facility Information

  • Registration Details

  • Food Product Categories

  • U.S. Agent Designation

  • Certification Statement

  • Signature Block

What it handles

  • Facility Information

  • Registration Details

  • Food Product Categories

  • U.S. Agent Designation

  • Certification Statement

  • Signature Block

Required documents

  • Facility Information

    Legal name, physical address, trade names, and operational location details of the food facility

    PDF, DOCX, TXT

  • Parent Company Details

    Parent company legal entity information, ownership structure, and country of incorporation if applicable

    PDF, DOCX

  • Food Product Categories

    List of all food products manufactured, processed, packed, or held with FDA product category codes

    PDF, DOCX, XLSX

Supporting documents

  • US Agent Authorization

    Signed agreement from designated US agent for foreign facilities confirming acceptance of responsibilities

    PDF, DOCX

  • Exemption Documentation

    Supporting documentation for any claimed exemptions under 21 CFR 1.226

    PDF, DOCX

  • Previous Registration Records

    Prior FDA registration numbers and renewal documentation for existing facilities

    PDF, DOCX

Why teams use it

Generate FDA-compliant registration documents in under 10 minutes

Eliminate errors with AI-guided prompts for all required information fields

Ensure accurate certification statements that meet federal standards

Reduce document preparation time by 95% compared to manual drafting

Maintain consistent compliance across multiple facility registrations

Questions

What facilities are required to register with the FDA?

Under 21 CFR Part 1, Subpart H, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with FDA. Exemptions exist for farms, retail food establishments, restaurants, and facilities regulated exclusively by USDA. CaseMark helps determine if your facility requires registration and generates appropriate documentation.

What is a US agent and when is one required?

A US agent is a required designee for all foreign food facilities who serves as the communication liaison between FDA and the facility. The agent must be physically located in the United States, available during business hours, and authorized to represent the facility for FDA communications and inspection scheduling. CaseMark generates compliant US agent designation sections with all required information.

How often must food facility registration be renewed?

FDA food facility registration must be renewed biennially during the period from October 1 through December 31 of each even-numbered year. Facilities must also update their registration within 60 calendar days of any change to required information. CaseMark includes proper renewal language and can help track your renewal obligations.

What happens if I provide incorrect information on my FDA registration?

Providing false information on FDA food facility registration can result in serious consequences including administrative detention of food articles, civil monetary penalties, and potential criminal prosecution. The registration includes a certification under penalty of law that all information is true and accurate. CaseMark helps ensure accuracy by systematically collecting and organizing all required information according to FDA specifications.

Can I submit my food facility registration on paper or must it be electronic?

Most facilities must submit registration electronically through the FDA Unified Registration and Listing System (FURLS) or FDA Industry Systems. Paper submission is only available for facilities that qualify for specific exemptions. Upon successful submission, you'll receive a registration number that must be retained and provided upon FDA request. CaseMark prepares your documentation for electronic submission with complete filing instructions.

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