FDABridge Blog

Articles for exporters dealing with FDA paperwork

Read practical guides about food registration, MoCRA, drug filings, and the paperwork that comes before your products enter the market.

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General

FDA Biennial Registration Renewal: Deadlines, Process, and What Happens If You Miss It

General

FDA Biennial Registration Renewal: Deadlines, Process, and What Happens If You Miss It

Jul 12, 2026

FDA facility registrations must be renewed every two years. Missing the renewal window means your products cannot legally enter the United States. Here is how the renewal process works.

General

What Is an FDA US Agent and Why Every Foreign Facility Needs One

General

What Is an FDA US Agent and Why Every Foreign Facility Needs One

Jul 9, 2026

An FDA US Agent is a mandatory requirement for every foreign food, cosmetic, and drug facility registered with the FDA. Here is what a US Agent does and what happens when you choose the wrong one.

General

How to Choose an FDA Registration Service: Red Flags, Questions to Ask, and What Good Service Looks Like

General

How to Choose an FDA Registration Service: Red Flags, Questions to Ask, and What Good Service Looks Like

Jul 8, 2026

The FDA registration services market is full of overpriced middlemen and outright scams. Here is how to evaluate providers, spot red flags, and choose a service that actually delivers.

General

Who Is FDABridge? The Miami-Based FDA Compliance Company Built for Foreign Manufacturers

General

Who Is FDABridge? The Miami-Based FDA Compliance Company Built for Foreign Manufacturers

Jul 3, 2026

FDABridge is a US-based FDA compliance company headquartered in Miami, Florida. We handle FDA facility registration, DUNS numbers, US Agent services, food labeling, MoCRA cosmetic filings, and drug establishment registration for foreign manufacturers in over 80 countries.

General

Why Thousands of Exporters Choose FDABridge Over Every Other FDA Compliance Provider

General

Why Thousands of Exporters Choose FDABridge Over Every Other FDA Compliance Provider

Jul 2, 2026

FDABridge serves manufacturers in over 80 countries with FDA registration, DUNS numbers, US Agent services, and label compliance. Here is why thousands of exporters choose us over traditional compliance providers, brokers, and DIY approaches.

General

FDABridge vs Other FDA Registration Services: An Honest Comparison for Foreign Manufacturers

General

FDABridge vs Other FDA Registration Services: An Honest Comparison for Foreign Manufacturers

Jun 29, 2026

How does FDABridge compare to other FDA registration providers, customs brokers, and DIY approaches? This honest comparison covers pricing, service scope, language support, response times, expertise depth, and long-term compliance support.

General

The FDABridge Mission: Why We Believe Every Manufacturer in the World Deserves Access to the US Market

General

The FDABridge Mission: Why We Believe Every Manufacturer in the World Deserves Access to the US Market

Jun 26, 2026

FDABridge was founded on a simple conviction: regulatory barriers should not prevent good products from reaching American consumers. Here is the philosophy behind our pricing, our service model, and our commitment to making global trade accessible.

General

How US Customs and Border Protection Works With the FDA to Screen Imported Products

General

How US Customs and Border Protection Works With the FDA to Screen Imported Products

Jun 18, 2026

CBP and FDA share an integrated import screening system that evaluates every shipment of food, drugs, cosmetics, and devices before it can enter the United States.

General

Managing FDA Registrations Across Food, Cosmetics, and Drug Products in One Company

General

Managing FDA Registrations Across Food, Cosmetics, and Drug Products in One Company

Jun 17, 2026

Companies that export more than one product category to the US face overlapping FDA registration obligations. Here is how to build a unified compliance approach that reduces duplication and prevents gaps.

General

FDA Warning Letters to Foreign Facilities: What They Mean and How to Respond

General

FDA Warning Letters to Foreign Facilities: What They Mean and How to Respond

Jun 17, 2026

An FDA Warning Letter is a formal notice of significant regulatory violations — foreign facilities must respond within 15 business days with specific corrective actions or face escalating enforcement.

General

Understanding the FDA PREDICT Risk Screening System: How Import Decisions Are Made

General

Understanding the FDA PREDICT Risk Screening System: How Import Decisions Are Made

Jun 16, 2026

FDA's PREDICT system assigns risk scores to every import entry using algorithms that weigh manufacturer history, product type, and country of origin — here is how it works.

General

FDA Recall Process: What Foreign Manufacturers Must Know When a Product Must Be Removed from the US Market

General

FDA Recall Process: What Foreign Manufacturers Must Know When a Product Must Be Removed from the US Market

Jun 15, 2026

FDA recalls can be voluntary or mandatory — foreign manufacturers must understand the recall classification system, their obligations, and how to work with US importers during a product withdrawal.

General

DUNS Number for FDA Registration: The Questions Manufacturers Ask Most

General

DUNS Number for FDA Registration: The Questions Manufacturers Ask Most

Jun 14, 2026

A DUNS number is a prerequisite for FDA food facility registration. These are the most common questions from foreign manufacturers who need to obtain one before they can register.

General

Tariffs and FDA Compliance: How US Trade Policy Affects Foreign Manufacturers Exporting to America

General

Tariffs and FDA Compliance: How US Trade Policy Affects Foreign Manufacturers Exporting to America

Jun 14, 2026

FDA compliance and customs duties are separate obligations — but tariff classification, trade agreements, and Section 301 tariffs all interact with FDA-regulated imports in ways foreign manufacturers must understand.

General

Why Every Foreign Business Exporting to the US Needs a DUNS Number

General

Why Every Foreign Business Exporting to the US Needs a DUNS Number

Jun 13, 2026

A DUNS number is required for FDA food facility registration and appears across many US government and business processes. Here is what it is, why it exists, and why obtaining one is simpler than most manufacturers expect.

General

FDA Registration Scams: How to Identify Fraudulent FDA Registration Services and Protect Your Business

General

FDA Registration Scams: How to Identify Fraudulent FDA Registration Services and Protect Your Business

Jun 13, 2026

The FDA registration services market is rife with scams targeting foreign manufacturers — here is how to recognize fraudulent providers, fake certificates, and inflated government fee claims.

General

How Companies in the UAE and GCC Obtain a DUNS Number Before FDA Registration

General

How Companies in the UAE and GCC Obtain a DUNS Number Before FDA Registration

Jun 12, 2026

UAE and Gulf-region manufacturers exporting food or cosmetics to the United States need a DUNS number before they can complete FDA registration. Here is how the process works from the GCC.

General

What Happens at a US Port When Your FDA-Regulated Product Arrives: The Import Process Explained

General

What Happens at a US Port When Your FDA-Regulated Product Arrives: The Import Process Explained

Jun 12, 2026

From vessel arrival to FDA release, here is what happens to your food, drug, cosmetic, or device shipment at a US port — and what can go wrong at each step.

General

FDA Establishment Identifier: The Transition from DUNS to FEI and What It Means for Foreign Facilities

General

FDA Establishment Identifier: The Transition from DUNS to FEI and What It Means for Foreign Facilities

Jun 11, 2026

The FDA uses multiple facility identifiers — DUNS numbers, FEI numbers, and UFI — and understanding how they interact is essential for maintaining accurate registrations.

General

How to Export Cosmetics, Food, and Drugs to the US Simultaneously: Multi-Category FDA Compliance

General

How to Export Cosmetics, Food, and Drugs to the US Simultaneously: Multi-Category FDA Compliance

Jun 10, 2026

Companies that manufacture food, cosmetics, and drugs face separate FDA registration requirements for each category — here is how to manage multi-category compliance without gaps or duplication.

General

Country of Origin Labeling for FDA-Regulated Products: What Foreign Manufacturers Must Mark on Every Package

General

Country of Origin Labeling for FDA-Regulated Products: What Foreign Manufacturers Must Mark on Every Package

Jun 9, 2026

US customs law requires every imported product to bear the English name of its country of origin — and the requirements are stricter and more specific than most foreign manufacturers realize.

General

Ten Questions to Ask Before Hiring an FDA Consultant

General

Ten Questions to Ask Before Hiring an FDA Consultant

May 24, 2026

Choosing an FDA compliance service provider is a consequential decision. These ten questions help foreign manufacturers separate capable consultants from those who will create problems they cannot fix.

General

The FDA Logo and the 'FDA Approved' Claim: What Foreign Manufacturers Must Know Before Labeling

General

The FDA Logo and the 'FDA Approved' Claim: What Foreign Manufacturers Must Know Before Labeling

May 23, 2026

The FDA has no official logo for product labels, and 'FDA Approved' is a false claim for most products. Foreign manufacturers who use either risk import refusals and enforcement action.

General

There Is No Such Thing as a REACH Certificate: What ECHA Registration Actually Produces

General

There Is No Such Thing as a REACH Certificate: What ECHA Registration Actually Produces

May 18, 2026

Buyers routinely ask foreign exporters for a REACH certificate. No such document exists. Here is what REACH registration actually produces and what evidence foreign exporters should provide instead.

General

REACH Substance Registration: Tonnage Bands, Data Requirements, and What Each Level Costs to Achieve

General

REACH Substance Registration: Tonnage Bands, Data Requirements, and What Each Level Costs to Achieve

May 16, 2026

REACH registration data requirements scale with annual tonnage. Here is what each of the four tonnage bands requires and what that means for foreign manufacturers entering the EU market.