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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
+1 855-389-7344
info@itbholdingsllc.com
FDA

 

Ensure your food or dietary supplement business stays compliant. Expert assistance with FDA Facility Registration, Prior Notice, FSVP, Label Reviews, and Inspection or Detention support.

 

Food Compliance Services
FDA
Regulatory Services

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Our regulatory experts handle your FDA requirements accurately and efficiently, so you can stay focused on your food business.

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Food Facility Registration

Food Facility Registration

Complete management of your FDA food facility registration and biennial renewals to ensure compliance.

➧ PROCEED TO REGISTRATION
Supplement Registration

Supplement Registration

Ensuring specialized compliance for vitamin and supplement facilities per FDA requirements.

➧ GET THE SERVICE
Food Canning Establishment

Food Canning Establishment

Handling FCE and SID filings for acidified and low-acid food commercial processors.

➧ SUBMIT FCE DATA
Prior Notice

Prior Notice

Expedited filing of Prior Notice for incoming food shipments to prevent border holds.

➧ FILE PRIOR NOTICE
FSVP Compliance

FSVP

Development of Foreign Supplier Verification Program to confirm suppliers meet U.S. safety standards.

➧ GET FSVP HELP
Label Review

Label Review

Comprehensive audit of nutrition panels and claims to ensure compliance with 21 CFR labeling laws.

➧ UPLOAD FOR REVIEW
FDA Detention

FDA Detention

Strategic advocacy and technical support to resolve FDA detentions and release products.

➧ RESOLVE DETENTION
FDA Inspection

FDA Inspection

Mock audits and readiness training to prepare your facility for upcoming FDA inspections.

➧ PREP INSPECTION
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Deal
35% off

FDA Food Facility Registration (FFR)
&
Foreign Supplier Verification Program (FSVP) Services

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U.S. FDA Food Compliance Service



U.S. FDA Food Facility Registration and Compliance


Professional assistance for domestic and foreign food facilities that manufacture, process, pack or hold FDA-regulated food products intended for the United States. Services may include initial registration, biennial renewal, U.S. Agent support, registration updates and related food-import compliance guidance.

U.S. FDA Food Facility Registration and compliance support for domestic and foreign food companies

Biennial Service Fee

$180

U.S. Agent Included

1

Food Facility Registration

Prepare a new FDA food facility registration using the legal company name, physical address, facility activities, emergency contacts and applicable food product categories.

2

Biennial Renewal

Review and renew an existing registration during the applicable biennial renewal period so the facility information remains current and active.

3

U.S. Agent and Updates

Coordinate U.S. Agent acceptance for foreign facilities and assist with changes to ownership, operator, address, contacts, activities and product categories.

4

Related FDA Compliance

Address related requirements such as Prior Notice, FSVP, food labeling, preventive controls, traceability, importer coordination and shipment documentation.

Examples of FDA-Regulated Food Products

Coffee
Tea
Cocoa
Chocolate
Cheese
Olive Oil
Palm Oil
Rice
Spices
Wine
Champagne
Fruits

Important: FDA food facility registration is not product approval, certification or endorsement by FDA. Depending on the product, company role and shipment, additional regulatory requirements may apply.

A practical FDA compliance service for U.S. facilities and foreign manufacturers, exporters, importers, distributors, warehouses, co-packers and private-label suppliers.

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