FDA Qualified Facility Wizard

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.