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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FoodJul 10, 2026

FDA Preventive Controls Qualified Individual: What Foreign Food Facilities Must Know About PCQI Training

Every food facility subject to FSMA Preventive Controls must have a trained Preventive Controls Qualified Individual overseeing its food safety plan — here is what the requirement means for foreign manufacturers.

FoodJul 9, 2026

Exporting Frozen and Refrigerated Foods to the United States: Cold Chain and FDA Compliance

Frozen and refrigerated food exports to the US must maintain documented cold chain integrity from production through delivery — here are the FDA requirements that govern temperature-controlled imports.

FoodJul 1, 2026

Missed Food Facility Renewal: Check Status and Arrange Recovery

If a food registration was not renewed by the deadline, confirm its status with FDA and address registration and shipment obligations before resuming imports.

FoodJun 30, 2026

Import Alert 99-32: What Happens When You Refuse an FDA Inspection

Refusing or obstructing an FDA inspection triggers Import Alert 99-32 — Detention Without Physical Examination. Your products are automatically detained at every US port until you demonstrate corrective action. Here is how the process works and how to get off the Red List.

FoodJun 28, 2026

Why a Single FDA Compliance Partner Outperforms Fragmented Vendor Relationships

Foreign food manufacturers often cobble together compliance from multiple vendors — one for registration, another for labels, a third for FSVP. This fragmented approach creates blind spots, delays, and unnecessary cost. A unified compliance partner eliminates those risks.

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.

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.

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.

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.

FoodJun 11, 2026

FDA Food Facility Registration: The Questions First-Time Registrants Ask Before Filing

First-time FDA food facility registrants have common questions about who must register, what the process involves, and what happens after registration. Here are direct answers.

FoodJun 10, 2026

How FDA's 2018 Guidance on Food Facility Registration Clarified the Farm Exemption

In 2018, FDA released a final guidance document answering questions about who must register under FSMA. The guidance clarified the farm exemption, mixed-type facilities, and retail food establishments — with lasting practical implications.

FoodJun 9, 2026

Exporting Food and Consumer Products to the United States in 2025: What Foreign Manufacturers Must Know

The US is the world's largest single-country import market. For foreign manufacturers, entering it means dealing with FDA, CBP, and a set of documentation requirements that apply before the first shipment arrives.

FoodMay 22, 2026

Low-Acid and Acidified Foods: When FDA FCE Registration and SID Filings Apply

How to classify a covered acidified or low-acid canned food, distinguish FCE from an SID, and prepare a qualified scheduled process without mistaking filing for FDA approval.

FoodMay 21, 2026

FDA Unannounced Inspections of Foreign Facilities: What FSMA Changed and How to Prepare

FSMA gave the FDA authority to inspect foreign food facilities without prior notice and to deny US market access to facilities that refuse. Here is how unannounced inspections work and what foreign facilities must have ready.

FoodMay 20, 2026

FSVP Gap Analysis: Supplier Evidence for US Food Importers

US importers own their FSVP decisions. Foreign suppliers can make verification easier by organizing relevant, hazard-specific evidence and closing documented gaps.

FoodMay 19, 2026

FDA Import Alerts and DWPE: Scope, Shipment Decisions and Removal Requests

Check the specific alert, product and listing scope; distinguish detention from final refusal; and prepare an evidence-based FDA removal request where appropriate.

FoodMay 15, 2026

How a Foreign Company Can Export Food to the United States: The FDA Requirements

Map the facility, importer and shipment roles before exporting food to the US. Check registration exemptions, UFI, US Agent, FSVP, labels and Prior Notice separately.

FoodApr 24, 2026

FDA Registration Numbers Explained: Check Your Filing Record

A food registration number, food DUNS/UFI and cosmetic FEI identify different records. Use this checklist to avoid confusing account access with registration status.