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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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.

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.

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.

GeneralJun 13, 2026

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

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.

GeneralJun 12, 2026

DUNS Numbers for UAE and GCC Food Facilities: FDA Requirements

UAE and GCC food facilities use an FDA-accepted UFI, currently DUNS. Cosmetic facilities need FEI before submission. Check records and country-specific timing.

GeneralJun 12, 2026

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

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.

GeneralJun 11, 2026

FDA Facility Identifiers: Food DUNS/UFI and Cosmetic FEI

FDA has not universally replaced DUNS with FEI. Food registration uses an accepted UFI, currently DUNS; cosmetic facilities need FEI before submission.

GeneralJun 10, 2026

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

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.

GeneralJun 9, 2026

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

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.

GeneralMay 24, 2026

Ten Questions to Ask Before Hiring an FDA Consultant

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.

GeneralMay 23, 2026

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

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.

GeneralMay 18, 2026

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

What an ECHA registration number demonstrates, which EEA party owns the duty, and which records a buyer should request instead of a generic certificate.

GeneralMay 16, 2026

REACH registration: tonnage, existing data and the right filing route

Identify the EU/EEA registration role, annual tonnage, data access and work that needs a defined quotation.

GeneralMar 18, 2026

REACH for Non-EEA Manufacturers: Substance, Importer and Representative Roles

Check the substance and EEA importer first. An eligible non-EEA manufacturer may appoint an EEA Only Representative; registration and data duties depend on the activity and tonnage.