The document outlines the requirements for food facility registration with the US FDA under the Bioterrorism Act for both domestic and foreign facilities. It explains the need for foreign facilities to designate a US agent, details the registration process, and provides a food facility registration form. The document also offers consulting services to assist with FDA registration and compliance for various types of food businesses.

1. US FDA Food Facility Registration (Bioterrorism Act) is required for both domestic and foreign facilities
that manufacture, process, pack, or hold food for consumption in the United States.
Foreign facilities must designate a United States agent (U.S. agent) for purposes of registration. The agent
is required to reside or maintain a place of business in the United States and to be physically present in the
United States. The U.S. agent acts as a communications link between FDA and the foreign facility for both
emergency and routine communications. The U.S. agent will be the person FDA contacts when an
emergency occurs, unless the registration specifies under 1.233(e) another emergency contact.
First Choice Consulting Services Regulatory expert team can help you with proper registration of your
Food, Beverage and Dietary supplement facilities with US FDA and by acting as your Unites States Agent.
We submit all of the required United States Food and Drug Administration (FDA) Food Facility
Registration information on behalf of you and provide you FDA assigned 11 digit FDA Registration
number.
For Fee and Payment information, please visit www.fdaregistration-consulting.com
Email signed completed US FDA Food Facility Registration form at firstchoice_consulting@yahoo.com
We are always happy to help you. If you have any questions or need any U.S. FDA Food, Beverage and
Dietary supplement regulatory assistance, please feel free to contact us.
FDA Food Facility Registration Form
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2. New FDA Food Facility Registration.
A new Owner of a previously registered Food Facility with FDA.
Name of the previous Owner of the facility: _____ ______________________________________
Title Complete Name
Previous Owner's 11 digit FDA Registration number: ____________________________________
Facility Name: _______________________________________________________________________
(Please include Business Entity eg. corporation, limited, company, etc, if any)
Business Type: Manufacturer Processer Packer Distributor Importer Broker
Warehouse Others: ______________________________________________
Do you take physical possession of the goods? Yes No
Street Address: ______________________________________________________________________
City: _____________________ State/Province: ______________________ ZIP/Postal code: ________
Country: ______________________________ Email: _______________________________________
Telephone: ____________________________ Telephone Extensions (if any): ___________________
Fax: __________________________________ Website: _____________________________________
Street Address: ______________________________________________________________________
City: _____________________ State/Province: ______________________ ZIP/Postal code: ________
Country: ______________________________ Email: _______________________________________
Telephone: ____________________________ Fax: _________________________________________
Parent Company Name: _______________________________________________________________
(Please include Business Entity eg. corporation, limited, company, etc, if any)
Street Address: ______________________________________________________________________
City: _____________________ State/Province: ______________________ ZIP/Postal code: ________
Country: ______________________________ Email: _______________________________________
Telephone: ____________________________ Phone Ext.: __________ Fax: ____________________
TYPE OF REGISTRATION
COMPANY INFORMATION
PREFERRED MAILING ADDRESS
PARENT COMPANY INFORMATION (if applicable)
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FDA Food Facility Registration Form
Print Form

3. Other Business Trading Names (Facility Also Known As or Doing Business As) if any,
1. _____________________________________________________________________________
2. _____________________________________________________________________________
3. _____________________________________________________________________________
4. _____________________________________________________________________________
Name of Owner / Operator: _____________________________________________________________
Street Address: ______________________________________________________________________
City: _____________________ State/Province: ______________________ ZIP/Postal code: ________
Country: ______________________________ Email: _______________________________________
Telephone: ____________________________ Fax: _________________________________________
Contact Name: _____ / _____________________/_____________________/_____________________
Title First Name Middle Name Last Name
Job Title: ______________________________ Email: ______________________________________
Emergency Contact Phone: ____________________________________ Phone Ext.: ______________
Whether your Facility operates on a seasonal basis?
No
Yes (If yes, Harvest Period I: __________/__________ Harvest Period II: _________/________)
Start Month End Month Start Month End Month
Ambient Storage (neither frozen nor refrigerated) Refrigerated Storage Frozen Storage
Food for Human Consumption Food for Animal Consumption Both
ALTERNATE TRADE NAMES
SEASONAL FACILITY DATES OF OPERATION (Optional)
TYPES OF STORAGE (for warehouse/holding facility)
GENERAL PRODUCT CATEGORIES
FACILITY EMERGENCY CONTACT INFORMATION
FACILITY OWNER / OPERATOR INFORMATION
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4. ∗ List all major Products that your company handles.
∗ Please refer below for Product Category and Type of activity conducted at the facility.
Product Name Product Category Type of activity
conducted at the facility
1.
2.
3.
4.
5.
6.
7.
8.
FDA will be permitted to inspect the facility at the time and in the manner permitted by the
Federal Food, Drug, and Cosmetic Act.
PayPal Transaction Number (ID): ________________________________________________________
Date of Payment: _ _ - _ _ - 201__
Comments (If any):
PRODUCT INFORMATION
PAYMENT INFORMATION
INSPECTION STATEMENT
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5. Product Categories:
1. Acidified Foods 14. Dressing And Condiments 27. Multiple Food Dinners, Gravies,
Sauces And Specialties
2. Alcoholic Beverages 15. Fisher / Seafood Product Categories
A. Fin Fish, Whole Or Filet
B. Shellfish
C. Ready To Eat (Rte) Fishery Products
D. Processed And Other Fishery Products
28. Nuts And Edible Seed Product
Categories
A. Nut And Nut Products
B. Edible Seed And Edible Seed
Products
3. Baby (Infant And Junior) Food Products
Including Infant Formula
16. Food Additives, Generally Recognized
As Safe (GRAS) Ingredients, Or Other
Ingredients used for processing
29. Prepared Salad Products
4. Bakery Products, Dough Mixes, or
Icings
17. Food Sweeteners (Nutritive) 30. Shell Egg And Egg Product
Categories
A. Chicken Egg And Egg Products
B. Other Eggs And Egg Products
5. Beverage Bases 18. Fruit And Fruit Products
A. Fresh Cut Produce
B. Raw Agricultural Commodities
C. Other Fruit And Fruit Products
31. Snack Food Items (Flour, Meal or
Vegetable Base)
6. Candy Without Chocolate, Candy
Specialties and Chewing Gum
19. Fruit Or Vegetable Juice, Pulp Or
Concentrate Products
32. Spices, Flavors, And Salts
7. Cereal Preparations, Breakfast Foods,
Quick Cooking / Instant Cereals
20. Gelatin, Rennet, Pudding Mixes, Or Pie
Fillings
33. Soups
8. Cheese And Cheese Product Categories
A. Soft, Ripened Cheese
B. Semi-Soft Cheese
C. Hard Cheese
D. Other Cheeses And Cheese Products
21. Ice Cream And Related Products 34. Soft Drinks And Waters
9. Chocolate And Cocoa Products 22. Imitation Milk Products 35. Vegetable Product Categories
A. Fresh Cut Products
B. Raw Agricultural Commodities
C. Other Vegetable And Vegetable Products
10. Coffee And Tea 23. Low Acid Canned Food (LACF) Product 36. Vegetable Oils (Includes Olive Oil)
11. Color Additives For Foods 24. Macaroni Or Noodle Products 37. Vegetable Protein Products
(Simulated Meats)
12. Dietary Conventional Foods or Meal
Replacements (Includes Medical Foods)
25. Meat, Meat Products And Poultry (FDA
Regulated)
38. Whole Grains, Miller Grain
Products (Flours), or Starch
13. Dietary Supplement Categories
A. Proteins, Amino Acids, Fats And Lipid
Substances
B. Vitamins And Minerals
C. Animal By-Products And Extracts
D. Herbals And Botanicals
26. Milk, Butter, Or Dried Milk Products
If none of the above food categories apply, then print the applicable food category or categories (that does not or do not appear above)
Type of activity conducted at the facility:
1. Warehouse / Holding Facility (e.g. storage facilities, including storage tanks, grain elevators)
2. Acidified / Low Acid Food Processor 5.Commissary 8. Manufacturer / Processor
3. Interstate Conveyance Caterer / Catering Point 6. Contract Sterilizer 9. Repacker / Packer
4. Molluscan Shellfish Establishment 7. Labeler / Relabeler 10.Salvage Operator (Reconditioner)
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6. First Choice Consulting Services and the undersigned party have today entered into an agreement
regarding the provision of consulting services on the terms and conditions laid out in this Agreement.
• The services provided by First Choice Consulting Services will be performed in a professional
manner in accordance with generally accepted industry standards.
• The Client agrees to provide accurate and sufficient information, adequate technical assistance
and documentation, required for First Choice Consulting Services to be able to perform the
Services. The Client shall promptly provide further information that First Choice Consulting
Services reasonably deems relevant to perform the task.
• The Client is solely responsible for the scientific accuracy, material facts and completeness of
information provided to First Choice Consulting Services.
• Customer authorizes First Choice Consulting Services to submit the furnished FDA Registration
information to the U.S. Food and Drug Administration (FDA) or other agency required by law.
• For the Services provided by First Choice Consulting Services, Customer agrees to pay First
Choice Consulting Services the fees set forth in a quote issued by First Choice Consulting
Services to Customer or as otherwise agreed to by First Choice Consulting Services and
Customer plus any applicable taxes or other charges.
• The Parties agree to make all reasonable efforts, in good faith, to resolve any dispute arising
from implementation of this agreement through informal discussions and the development of
mutual satisfactory options.
• First Choice Consulting Services liability in whatever kind or nature cannot exceed the fee for
performing the task.
• This Agreement shall terminate automatically upon completion by First Choice Consulting
Services of the Services required by this Agreement or on December 31, 2015.
• First Choice Consulting Services is a Private business entity and is not affiliated with U.S. FDA.
By singing below, Customer agrees to be bound by this Agreement:
Company Name: _________________________ Signature: _____________________________________
Date: _ _ - _ _ - 201__ Authorized Person Name: _________________________
(Managing Director, Proprietor, General Manager, etc.)
Place: __________________________________ Job Title: ______________________________________
AGREEMENT
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