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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
FDA

 

 

LOWEST SERVICE FEES

 

 

Why Pay More for Less?

 

FDA FEES
LOWEST FDA REGISTRATION SERVICE FEES
  • No hidden costs
  • No forced options
  • Only what you need or want
  • Reduced fee for multiple services
  • Reduced fee for multiple companies
  • U.S. Agent Service included
  • Same Day Service for extra fee

Some registrations require additional User Fees – Medical Device Establishment and Drug Establishment. You will be informed as expected, upon request.

Renew or get your company's FDA Registration. Contact ITB HOLDINGS LLC, today. Save Time & Money.
FDA REGISTRATION FEES

Are you planning on exporting these popular products to the United States?

  • Live meat animals
  • Meats
  • Fish and shellfish
  • Dairy
  • Vegetables
  • Fruits
  • Nuts
  • Coffee, tea and spices
  • Grains
  • Candy and sugar
  • Chocolate and cocoa
  • Beverages
  • Liquor
  • Dietary supplements
  • Medical devices
  • Cosmetics
  • Over-the-Counter (OTC) products.

If your response is yes, then here is your chance to expand to the U.S. market, today. But first, your company needs to register its facility or establishment with the U.S. Food and Drug Administration (U.S. FDA).

When seeking the assistance of ITB HOLDINGS LLC for the purpose of FDA Registration and or Compliance, expect two types of fees, here:

Service Fees.

User Fees.

FDA SERVICE FEES

Service Fees are paid to ITB HOLDINGS LLC, for the following:

Enjoy More Payment Options, here

Payment methods accepted for ITB HOLDINGS LLC’s invoices are Debit / Credit Card, Bancontact, Giropay, iDEAL, Sofort, Apple Pay, Google Pay, PayPal, SEPA Direct Debit, Stripe, Payments in multiple currencies.

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Food Facility Registration
$180.00
Food Label Review
$99.00
FSVP
$350.00
Prior Notice
$25.00
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LIMITED | OFFER

FOOD
FACILITY

$99.00

  • Company Registration
  • U.S. Agent Service
ANNUAL SERVICE FEE
  • Food Canning Establishment (FCE) Registration is not included.
FDA REGISTRATION
BIENNIAL FEE
FDA REGISTRATION
BIENNIAL FEE
FDA REGISTRATION
SERVICE
FDA REGISTRATION
ANNUAL FEE
FDA COMPLIANCE
FOOD LABEL
FDA COMPLIANCE
STANDARD FEE
FDA REGISTRATION
ANNUAL FEE
FDA REGISTRATION
ANNUAL FEE
FDA REGISTRATION
ANNUAL FEE
FDA REGISTRATION
ANNUAL FEE
FDA REGISTRATION
ANNUAL FEE
FDA COMPLIANCE
ANNUAL FEE
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FDA REGISTRATION requests must include:

  • Full company name
  • Complete physical address
  • First and last name of CEO or Manager
  • Email and telephone of CEO or Manager
  • Product details
  • Company DUNS Number
    Data Universal Numbering System, DUNS from Dun & Bradstreet Inc. Free in 30 days.
GET
50% OFF
REQUEST MULTIPLE REGISTRATIONS AT THE SAME TIME
Great Opportunity for companies offering FDA Registration Services to Food Facilities in Canada, Mexico, Brazil, Australia, India, Pakistan, Russia, China, South Korea, Japan, Europe and Africa!
USER FEES

User Fees are paid to the U.S. Treasury.

Payment methods

  • electronic check (ACH also known as eCheck)
  • credit card (Discover, VISA, MasterCard, American Express).
PAYMENT OF USER FEES

An FDA Payment Account is required. We can assist.

U.S. Department of Treasury
TREAS NYC
33 Liberty St
New York, NY 10045
Account Number: 75060099
Routing number: 021030004
SWIFT: FRNYUS33
Beneficiary:
FDA
8455 Colesville Rd, 14th Floor
Silver Spring, MD 20993-0002
FDA’s Tax Identification Number: 53-0196965.

CURRENT USER FEES

$9,280 | Medical Device Establishment Registration (FY 2025)

Over-The-Counter Monograph Drug User Fees (OMUFA) (FY 2024)

▪ Monograph Drug Facility (MDF) Facility Fee: $34,166.

▪ Contract Manufacturing Organization (CMO) Facility Fee: $22,777.

These fees are effective through September 30, 2024.

They are now required to register an establishment manufacturing, among other products,

  • Sunscreen
  • Antidandruff shampoo
  • Toothpaste containing fluoride
  • Antiperspirant deodorant
  • Cold and cough products
  • Hand Sanitizers