ITB Holdings LLC
ITB Holdings LLC is a U.S. Agent and FDA compliance service provider, assisting foreign companies with FDA registration, U.S. Agent designation, and navigating complex U.S. FDA regulations for various products.
ITB Holdings LLC specializes in facilitating FDA registration and compliance for foreign companies looking to export to the United States. As an authorized U.S. Agent, they act as the primary point of contact between foreign facilities and the U.S. Food and Drug Administration, ensuring smooth communication and adherence to regulatory requirements. Their services cover a wide range of products, including Foods, Dietary Supplements, Alcoholic Beverages, Medical Devices, Drugs (Prescription and OTC), Cosmetics, and more. ITB Holdings LLC assists with crucial processes such as FDA registration, U.S. Agent designation, Prior Notice, Foreign Supplier Verification Program (FSVP), and FDA labeling compliance. With a commitment to simplifying the export process, ITB Holdings LLC helps companies expand their market reach by ensuring their facilities are registered and compliant with U.S. FDA standards. They offer expert guidance on regulatory nuances, helping clients avoid common pitfalls and maintain a strong compliance posture in the U.S. market.
About
**Who they are**
ITB Holdings LLC is a U.S. Agent and FDA compliance service provider that assists foreign companies with FDA registration and navigating U.S. FDA regulations.
**Expertise & scope**
* Serves as the designated U.S. Agent for foreign facilities and establishments engaged in manufacturing, preparation, propagation, compounding, or processing of medical devices imported into the United States.
* Assists foreign manufacturers, repackers, relabelers, and control laboratories involved in the manufacture, preparation, propagation, compounding, processing, or testing of human or veterinary drugs and human biological products, including API manufacturers.
* Provides FDA registration services for Food Facilities, including Food Canning Establishments (FCE) and Dietary Supplement Facilities.
* Offers services related to Drugs Establishments, including OTC Drugs and Hand Sanitizers.
* Supports Medical Devices Listing and Registration, including Personal Protective Equipment (PPE), Face Masks, and Respirators.
* Assists companies with FDA detention issues, including those related to inadequate Prior Notice or Import Alerts.
* Facilitates FDA registration renewal for Prescription Drug Establishments and Medical Devices Establishments.
**Reputation / proof points**
* Acts as the U.S. Agent for companies in over 100 countries, including Canada, Mexico, Brazil, Australia, India, Japan, China, and various European nations.
ITB Holdings LLC is a U.S. Agent and FDA compliance service provider that assists foreign companies with FDA registration and navigating U.S. FDA regulations.
**Expertise & scope**
* Serves as the designated U.S. Agent for foreign facilities and establishments engaged in manufacturing, preparation, propagation, compounding, or processing of medical devices imported into the United States.
* Assists foreign manufacturers, repackers, relabelers, and control laboratories involved in the manufacture, preparation, propagation, compounding, processing, or testing of human or veterinary drugs and human biological products, including API manufacturers.
* Provides FDA registration services for Food Facilities, including Food Canning Establishments (FCE) and Dietary Supplement Facilities.
* Offers services related to Drugs Establishments, including OTC Drugs and Hand Sanitizers.
* Supports Medical Devices Listing and Registration, including Personal Protective Equipment (PPE), Face Masks, and Respirators.
* Assists companies with FDA detention issues, including those related to inadequate Prior Notice or Import Alerts.
* Facilitates FDA registration renewal for Prescription Drug Establishments and Medical Devices Establishments.
**Reputation / proof points**
* Acts as the U.S. Agent for companies in over 100 countries, including Canada, Mexico, Brazil, Australia, India, Japan, China, and various European nations.
Additional information
ITB Holdings LLC emphasizes that foreign establishments engaged in manufacturing or processing products for the U.S. market must designate a U.S. Agent. This agent is crucial for completing FDA registration and obtaining a registration number. The company also highlights that commercial activities in the U.S. cannot be conducted through the designated U.S. Agent. They offer services for various FDA-regulated products, including drugs, medical devices, and food products, and assist with compliance challenges such as FDA detention. Companies are advised to ensure their registrations are renewed before the deadline, particularly for Prescription Drug Establishments and Medical Devices Establishments.
Key Highlights
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ITB Holdings LLC serves as the U.S. Agent for companies in over 100 countries.
Source
“ITB HOLDINGS LLC is the U.S. Agent of companies in Canada, Mexico, Brazil, Australia, New Zealand, India, Pakistan, South Korea, Japan, China, Russia, Portugal, Greece, Italy, Spain, France, Belgium, Netherlands, Switzerland, Sweden, United Kingdom, Ireland, among more than 100 countries.”
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Assists foreign companies with FDA registration for medical devices, drugs, and food products.
Source
“Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment.”
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Provides FDA registration and renewal services for Prescription Drug Establishments and Medical Devices Establishments.
Source
“The following domestic and foreign companies must renew their registration before December 31, 2025, regardless of when the initial registration was completed: ▪ Prescription Drug Establishment. ▪ Medical Devices Establishment.”
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Offers assistance with FDA detention issues, including those arising from import alerts.
Source
“Some detentions are the result of the FDA’s Import Alert List of imported products manufactured by or exported by companies with detected patterns of noncompliance.”
Certifications & Trust Signals
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ITB Holdings LLC is a U.S. Agent and FDA compliance service provider.
Source
“ITB Holdings LLC is a U.S. Agent and FDA compliance service provider, assisting foreign companies with FDA registration, U.S. Agent designation, and navigating complex U.S. FDA regulations for various products.”
Buyer Snapshot
Best for
- Foreign companies needing a U.S. Agent for FDA registration.
- Manufacturers of medical devices, drugs, and food products.
- Companies facing FDA detention or import alerts.
How engagement typically works
- Service provider for FDA registration and compliance.
- Assists with regulatory navigation and requirements.
Typical deliverables
- Designated U.S. Agent services.
- FDA Establishment Registration.
- FDA Registration Renewal.
- Assistance with FDA detention.
Good to know
- Best when requiring a U.S. Agent for FDA compliance and registration.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $99.00 - $350.00
Notes:
Pricing varies by service; specific fees are listed on their website.
“$350.00; $180.00; $99.00; $350.00; $180.00”
HQ:
Orlando, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Find FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Foods, Dietary supplements, Cosmetics
Portfolio:
1-5
Onboarding time:
1–10 days
Pricing model:
Custom pricing
Starting from:
USD 299
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Registration Support:
Yes
Time Zone Coverage:
EST
Product Type:
devices, food, cosmetics, drugs
Service Types:
US Agent Services, FDA Registration/Listing Support, Label Review, Import Alert/Detention Resolution, Export Certificate
Annual Renewal Support:
Yes
Emergency Contact24x7:
Yes
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Requires DUNS Number for registration renewal.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Medical Devices, Drugs, Human Biological Products, Active Pharmaceutical Ingredients (APIs), Food Products, Dietary Supplements, OTC Drugs, Hand Sanitizers, Personal Protective Equipment (PPE), Face Masks, Respirators
Registration Support
Yes
Inspection Support
No
Recall Support
No
Emergency Contact24x7
No
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