• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • +1-757-224-0177
  • Contact
  • Accéder à MyFDA
  • Français
    • English
    • Español
    • Italiano
    • Deutsch
    • 中文
    • Portuguese
    • 日本語
Registrar

Registrar

Assistance with U.S. FDA Regulations

  • Français
    • English
    • Español
    • Italiano
    • Deutsch
    • 中文
    • Portuguese
    • 日本語
  • Enregistrement FDA
  • Nos Services
    • Enregistrement FDA
    • Enregistrement FDA des cosmétiques
    • Formations en Ligne
    • Sécurité alimentaire et FSMA
    • Etiquetage FDA
    • UDI et GUDID
    • Master Files
    • TTB Registration
  • Industries
    • Alimentaires et boissons
    • Compléments alimentaires
    • Dispositifs médicaux
    • Produits pharmaceutiques
    • Cosmétiques
    • Autre
  • Ressources
    • Ressources
    • Actualités
    • Evènements / Webinars
    • Outils
  • À propos
    • À propos
    • Contact

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
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • This field is hidden when viewing the form
  • 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.

Primary Sidebar

Contactez nous

 

144 Research Drive

Hampton, Virginia 23666 USA

 

+1-757-224-0177 

 

+1-757-224-0179

 

[email protected]

 
 
 
 

NOS EMPLACEMENTS

24/7 LIVE CHAT

Solutions

Enregistrement FDA

FDA Compliance Monitor

Etiquetage FDA

Voir tous

À propos

À propos

Ressources

Outils

Tarifs

Contact

 

Témoignages

Emplacements

Evènements

Associations

Téléphone: +1-757-224-0177

Fax: +1-757-224-0179

[email protected]

© 2025 Registrar Corp

144 Research Drive Hampton, Virginia 23666 USA
Conditions d'utilisation | Politique de confidentialité

  • Français
    • English
    • Español
    • Italiano
    • Deutsch
    • 中文
    • Portuguese
    • 日本語
    • Back
  • Enregistrement FDA
  • Nos Services
    • Enregistrement FDA
    • Enregistrement FDA des cosmétiques
    • Formations en Ligne
    • Sécurité alimentaire et FSMA
    • Etiquetage FDA
    • UDI et GUDID
    • Master Files
    • TTB Registration
    • Back
  • Industries
    • Alimentaires et boissons
    • Compléments alimentaires
    • Dispositifs médicaux
    • Produits pharmaceutiques
    • Cosmétiques
    • Autre
    • Back
  • Ressources
    • Ressources
    • Actualités
    • Evènements / Webinars
    • Outils
    • Back
  • À propos
    • À propos
    • Contact
    • Back

Attention: les établissements qui n’auront pas renouvelé leur enregistrement FDA en   devront se réenregistrer

Attention: les établissements pharmaceutiques et de dispositifs médicaux qui n’auront pas renouvelé leur enregistrement FDA en   devront se réenregistrer.

Se réenregistrer maintenant

Les établissements enregistrés à la FDA doivent renouveler leurs enregistrements avant le 31 décembre  

Les établissements pharmaceutiques et de dispositifs médicaux enregistrés à la FDA doivent renouveler leurs enregistrements avant le 31 décembre  

Renouveler Maintenant

Rappel

L’U.S. Food and Drug Administration (FDA) exige que tous les établissements agro-alimentaires, pharmaceutiques, et de dispositifs médicaux leurs enregistrements FDA entre le 1er octobre et le 31 décembre

Renouveler Maintenant

Attention

La période de renouvellement de l’U.S. FDA est TERMINEE depuis le 31 décembre

Si vous n’avez pas renouvelé avant la date limite, vous devez vous réenregistrer auprès de la FDA.

Réenregistrez-vous ou vérifiez que votre enregistrement a été renouvelé pour :

Se réenregistrer
Vérifier

Offre limitée

Obtenez 18 mois de service d’enregistrement et d’agent U.S. au tarif de 12 si vous vous enregistrez aujourd’hui.

Get Started