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Assistance with U.S. FDA Regulations

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FDA Qualified Facility Wizard

FDA Qualified Facility Wizard

Depending on the average value of your company’s food sales and unsold food inventory, your facility may be exempt from certain FDA food safety requirements, such as the development of a Hazard Analysis and Risk-based Preventive Controls (HARPC) Food Safety Plan and Supply-Chain Program.

Registrar Corp’s Qualified Facility Wizard can help determine whether your facility is eligible to file an attestation. Simply answer a few short questions about your company in the form below.

1Company Information
2Calculate Facility Status
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  • Enter the values of your business's gross sales of Food for Human Consumption and unsold food inventory (including those from affiliates and subsidiaries) for the previous three years.

    Registrar Corp's Qualified Facility Wizard will
    adjust the values for inflationValues are calculated as recommended by FDA guidance using the Implicit Price Deflators for Gross Domestic Product (GDP) available at FDA.gov:
    and estimate whether your facility is eligible to submit an attestation.
  • *Registrar Corp does not store monetary information entered into this tool.
  • Global Sales of Human Food
    You can determine your annual sales using resources such as:
    • Tax Forms (Gross Receipts, Sales, etc.)
    • Accounting Documents (Total Sales, Revenues from an Income Statement, etc.)
    • Invoices, Bills of Lading, etc.

    {{yearOne}}
    {{yearTwo}}
    {{yearThree}}

    Unsold Food Inventory
    You can determine the value of your unsold inventory using resources such as:
    • Insurance Policies
    • Invoices, Bills of Lading, etc.

    {{yearOne}}
    {{yearTwo}}
    {{yearThree}}
    Do your sales to
    qualified end-usersQualified end-users are either
    • Consumers
    • Restaurants or retail food establishments located in the same state as the facility, no more than 275 miles away, who sell the food directly to consumers.
    exceed those to all other purchasers?
    Please select a value.
  • The sum of your average annual sales and the market value of your unsold inventory is (less than $1,000,000).

    Your average annual sales are (less than $500,000) and your sales to qualified end-users exceeded that of sales to other purchasers.

    Based on this value, your facility may be eligible to submit an attestation as a very small businessqualified facility.

    Registrar Corp can provide guidance on submitting a Qualified Facility Attestation with FDA.

    To file a Qualified Facility Attestation with FDA:

    1. Download the FormDownload the Form
    2. Complete the form and either:
      Mail directly to FDA
      U.S. Food and Drug Administration
      (HFS-681)
      5100 Paint Branch Parkway
      College Park, MD 20740
      United States
      OR
      Mail to Registrar Corp to submit on your behalf
      Registrar Corp
      c/o QFA department
      144 Research Drive
      Hampton, VA
      23666 United States

    The sum of your average annual sales and the market value of your unsold inventory is

    Based on this value, your facility may not be eligible to submit an attestation.

    Instead, FDA may require your facility to have a HARPC Food Safety Plan. An FDA inspector may check for your Food Safety Plan during a food facility inspection.

    Registrar Corp's Preventive Controls Qualified Individuals (PCQI) can develop a HARPC Food Safety Plan for your facility or review a current plan for compliance.

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FDA has cancelled thousands of registrations that were not properly renewed or did not include
an accurate Unique Facility Identifier (UFI). If you need immediate assistance, Registrar Corp can help.

Notice: Medical Device and Drug establishments that did not renew their FDA registrations in   must re-register.


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FDA-registered facilities must renew their registrations by December 31,  

Medical Device and Drug establishments must renew their registrations by December 31,  

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Reminder

The U.S. Food and Drug Administration (FDA) requires that all registered food, medical device, and drug facilities renew their FDA registration between October 1 and December 31,

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Notice

The U.S. FDA Registration Renewal period CLOSED on December 31,

If you did not renew by the deadline, you must re-register with FDA.

Re-register or verify that your registration was renewed for :

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