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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FoodJun 22, 2026

FDA UFI Enforcement: Why Your DUNS Number Can Make or Break Your US Market Access

The FDA now actively verifies Unique Facility Identifiers during food facility registration. Facilities with missing, invalid, or unverifiable DUNS numbers face registration cancellation and loss of US market access.

DrugJun 22, 2026

FDA Drug Establishment Inspection: What Foreign Manufacturers Should Expect During a GMP Audit

FDA inspections of foreign drug facilities examine every aspect of CGMP compliance — here is what happens before, during, and after an FDA investigator arrives at your manufacturing site.

FoodJun 21, 2026

FDA Registration Is Not Certification: The Compliance Layers You Actually Need

Many foreign manufacturers believe FDA registration means they are approved to export to the United States. It does not. Registration is a directory listing, not a seal of approval. Real compliance requires multiple layers that most exporters overlook.

DrugJun 21, 2026

Exporting Hand Sanitizers and Antiseptic Products to the US: Why They Are OTC Drugs, Not Cosmetics

Hand sanitizers, antiseptic washes, and antibacterial soaps are regulated as OTC drugs in the United States — not as cosmetics — and require drug establishment registration, NDC listing, and monograph compliance.

DrugJun 20, 2026

Prescription Drug User Fee Act and Foreign Manufacturers: What PDUFA Fees Mean for Market Entry

PDUFA establishes annual establishment fees and application fees that every foreign drug manufacturer must pay to maintain FDA registration and submit drug applications.

CosmeticsJun 19, 2026

MoCRA Explained: What Foreign Cosmetic Exporters Must Know Before Shipping to the US

The Modernization of Cosmetics Regulation Act rewrites the rules for every cosmetic product entering the United States. Facility registration, product listing, adverse event reporting, and safety substantiation are now federal law — not optional best practices.

DrugJun 19, 2026

FDA Drug Labeling: OTC Drug Facts Panel vs Prescription Drug Labeling Requirements

OTC drugs require a Drug Facts panel under 21 CFR 201.66 while prescription drugs follow the Physician Labeling Rule — foreign manufacturers must apply the correct format for their product classification.

FoodJun 18, 2026

What Happens When a Foreign Food Facility Falls Out of FSMA Compliance

FSMA compliance is not a one-time event. Foreign food facilities that let their registration lapse or fail FSMA requirements face escalating consequences. Here is what the process looks like and how to recover.

GeneralJun 18, 2026

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

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.

GeneralJun 17, 2026

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

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.

GeneralJun 17, 2026

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

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.

FoodJun 16, 2026

Exporting Eggs and Egg Products to the USA: FDA, USDA and Facility Applicability

Separate shell eggs, USDA egg products and foods containing eggs. Check each site’s activities, registration exemptions, animal-health eligibility and import documents before shipment.

GeneralJun 16, 2026

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

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.

EUJun 15, 2026

CPNP: What the Acronym Means and What the Notification Process Actually Involves

CPNP stands for Cosmetic Products Notification Portal. It is the EU system for notifying cosmetic products before they go on sale in Europe. Here is what the notification process requires in practice.

GeneralJun 15, 2026

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

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.

GeneralJun 14, 2026

DUNS Number for FDA Registration: The Questions Manufacturers Ask Most

Check when FDA food registration needs a facility DUNS/UFI, how D&B lookup and updates differ from a new request, and which service fits.

GeneralJun 14, 2026

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

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.

GeneralJun 13, 2026

When a Foreign Business Needs a DUNS Number for FDA Food Registration

A DUNS number serves as FDA's currently accepted food facility UFI, while FEI and the FDA registration number serve different purposes. Check applicability and the facility record first.