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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.

Food

FDA Food Contact Substance Notification: What Foreign Packaging Manufacturers Must Know

Jul 28, 2026

Foreign packaging manufacturers must file a Food Contact Notification with the FDA before their materials can legally contact food sold in the United States.

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Food

Seafood HACCP for Foreign Exporters: FDA Requirements Under 21 CFR Part 123

Jul 27, 2026

Foreign seafood processors must implement a HACCP plan compliant with 21 CFR Part 123 before exporting fish and fishery products to the United States.

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Food

FDA Allergen Labeling: The Nine Major Allergens and What the FASTER Act Changed

Jul 26, 2026

US food allergen labeling now covers nine major allergens after the FASTER Act added sesame in 2023 — here is what foreign food manufacturers must include on every label.

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Food

Exporting Canned Food to the United States: FCE, SID, and Thermal Process Filing Requirements

Jul 25, 2026

Foreign canned food manufacturers must obtain FCE registration and file Scheduled Processes with the FDA before any thermally processed product can enter the US market.

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Food

FDA Nutrition Facts Panel: Format Requirements Foreign Manufacturers Get Wrong

Jul 24, 2026

The US Nutrition Facts panel has specific format rules that differ from every other country — here are the requirements foreign food manufacturers most frequently violate.

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Food

Food Safety Modernization Act Explained: How FSMA Changed US Food Imports Forever

Jul 23, 2026

FSMA shifted US food safety from reactive enforcement to proactive prevention — here is how each of its seven major rules affects foreign food manufacturers.

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Food

FDA Voluntary Qualified Importer Program: How VQIP Speeds Up US Customs Clearance

Jul 22, 2026

The FDA's Voluntary Qualified Importer Program offers expedited entry for food imports from facilities with strong compliance records — here is how to qualify.

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Food

Exporting Dairy Products to the United States: FDA Requirements and Common Pitfalls

Jul 21, 2026

Foreign dairy manufacturers face layered US regulatory requirements including FDA registration, Grade A standards, and specific labeling rules that differ from most export markets.

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Food

FDA Food Facility Registration for Contract Manufacturers: Who Registers When Multiple Parties Are Involved

Jul 20, 2026

When a brand owner contracts with a third-party manufacturer, both parties may need FDA food facility registration — here is how the rules apply to each arrangement.

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Food

Sanitary Transportation of Human Food: What the FSMA Rule Means for Foreign Exporters

Jul 19, 2026

The FSMA Sanitary Transportation Rule establishes requirements for vehicles, temperature controls, and records that affect how food reaches US ports from foreign origins.

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Food

FDA Juice HACCP Requirements: What Foreign Juice Manufacturers Must File Before Exporting to the US

Jul 18, 2026

Foreign juice processors must implement HACCP plans under 21 CFR Part 120 with a validated 5-log pathogen reduction step before any juice product can enter the United States.

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Food

FDA Prior Notice for Imported Food: What Foreign Exporters Must File Before Every Shipment

Jul 17, 2026

Every food shipment entering the United States requires an FDA Prior Notice filing. Here is what foreign exporters need to know about timelines, required data, and common filing mistakes.

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Food

Exporting Spices and Seasonings to the United States: FDA Requirements and Import Risks

Jul 17, 2026

Spices face some of the highest FDA refusal rates due to salmonella contamination, aflatoxin levels, and filth — here is what foreign spice exporters must prepare for.

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Food

FDA Infant Formula Registration: Why Foreign Manufacturers Face the Strictest US Import Requirements

Jul 16, 2026

Infant formula faces the most demanding FDA requirements of any food category — including premarket notification, mandatory nutrient levels, and strict quality control under 21 CFR Parts 106 and 107.

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Food

What Is the Foreign Supplier Verification Program and How It Affects Your Exports to the US

Jul 15, 2026

FSVP requires US importers to verify that every foreign food supplier meets US safety standards — and foreign manufacturers must provide the documentation to make that verification possible.

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Food

FDA Import Detention and Refusal: Why Shipments Get Held and How to Prevent It

Jul 14, 2026

FDA import detentions cost foreign food exporters thousands in port fees, re-export costs, and lost buyers. Here are the most common causes and how to avoid them.

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Food

FDA Food Additive Petition Process: How Foreign Manufacturers Get New Ingredients Approved for the US Market

Jul 14, 2026

Foreign food manufacturers who use ingredients not yet authorized in the US must file a Food Additive Petition or GRAS notification before those ingredients can legally appear in US food products.

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Food

Exporting Dietary Supplements to the United States: FDA Requirements for Foreign Manufacturers

Jul 13, 2026

Dietary supplements sold in the US must meet FDA facility registration, GMP, labeling, and ingredient requirements. Here is what foreign manufacturers need to know before entering the market.

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Food

Exporting Confectionery and Chocolate to the United States: FDA Standards of Identity and Labeling Rules

Jul 13, 2026

US chocolate and confectionery products must meet specific FDA standards of identity under 21 CFR Part 163 — and many foreign products do not qualify to use standard names.

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Food

FDA Third-Party Certification Program: How Accredited Audits Expedite US Food Imports

Jul 12, 2026

FDA's Accredited Third-Party Certification Program under FSMA allows certified foreign facilities to qualify for expedited import entry through VQIP and mandatory certification pathways.

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Food

FDA Food Labeling Requirements for Foreign Exporters: A Complete Compliance Guide

Jul 11, 2026

US food labels must meet strict FDA requirements for Nutrition Facts, ingredients, allergens, and claims. Here is what foreign exporters need to get right before shipping to America.

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Food

Exporting Tea and Coffee to the United States: FDA Requirements Foreign Producers Overlook

Jul 11, 2026

Tea and coffee imports face FDA requirements for facility registration, pesticide tolerances, labeling, and contaminant limits that many foreign producers overlook until shipments are detained.

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Food

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

Jul 10, 2026

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.

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Food

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

Jul 9, 2026

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.

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Food

Missed Your FDA Registration Renewal? Here Is What Happens and How to Recover

Jul 1, 2026

In 2019 alone, the FDA removed 47,635 food facility registrations for failure to renew. An expired registration shuts down US market access instantly. Understanding the consequences — and the recovery path — is essential for every foreign manufacturer.

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Food

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

Jun 30, 2026

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.

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Food

Why a Single FDA Compliance Partner Outperforms Fragmented Vendor Relationships

Jun 28, 2026

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.

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Food

FDA Food Facility Registration Renewal 2026: Prepare Now or Lose Market Access

Jun 25, 2026

The 2026 biennial renewal window opens October 1 and closes December 31. Facilities that miss the deadline will have their registrations expire, blocking all US imports. Here is what you need to know and do before the window opens.

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Food

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

Jun 22, 2026

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.

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Food

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

Jun 21, 2026

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.

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Food

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

Jun 18, 2026

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.

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Food

FDA Registration for Egg and Egg Product Manufacturers: What the Full Product Range Covers

Jun 16, 2026

Shell eggs are the most visible category, but the FDA registration requirement for egg products extends to liquid eggs, dried eggs, egg dishes, and dozens of egg-derived products. Here is the full scope.

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Food

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

Jun 11, 2026

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.

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Food

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

Jun 10, 2026

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.

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Food

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

Jun 9, 2026

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.

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Food

Low-Acid and Acidified Canned Foods: FDA FCE and SID Registration Requirements

May 22, 2026

Low-acid and acidified canned food producers must complete FCE and SID filings with the FDA before any shipment enters the United States. Here is what those filings require and why a process authority is non-negotiable.

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Food

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

May 21, 2026

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.

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Food

FSVP Gap Analysis: What Foreign Food Suppliers Must Document Before US Importers Come Checking

May 20, 2026

The Foreign Supplier Verification Program places compliance verification obligations on US importers — but the evidence comes from foreign manufacturers. Here is what a gap analysis reveals and what to fix first.

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Food

FDA Import Alert: What It Is, How Facilities Get Listed, and the Path to Removal

May 19, 2026

The FDA Import Alert places foreign facilities under automatic shipment detention, blocking every future shipment without individual examination. Here is how facilities get listed and what removal actually requires.

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Food

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

May 15, 2026

Exporting food to the US requires FDA facility registration, a DUNS number, a US Agent, Prior Notice, and compliant labeling. Here is how each piece fits together.

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Food

FDA Registration Numbers Explained: FEI, DUNS, and How the FDA Identifies Foreign Facilities

Apr 24, 2026

The FDA uses multiple identification numbers for foreign food and drug facilities — FEI, DUNS, and others. Understanding what each number means and how they relate is essential for foreign exporters.

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Food

FDA Inspections of Foreign Registered Facilities: What to Expect and How to Prepare

Apr 20, 2026

The FDA has authority to inspect foreign food and drug facilities. Understanding how inspections are triggered, what inspectors look for, and what the outcomes mean helps foreign manufacturers stay prepared.

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Food

FDA Food Facility Registration Step by Step: A Process Guide for Foreign Manufacturers

Apr 14, 2026

FDA food facility registration involves a specific sequence of steps — DUNS first, then US Agent, then the FDA filing itself. Foreign manufacturers who follow the correct order avoid the most common delays.

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Food

Why the FDA Rejects Food Facility Registrations: Common Mistakes Foreign Manufacturers Make

Apr 10, 2026

FDA food facility registration rejections are almost always preventable. The most common causes are DUNS mismatches, missing US Agent information, and incorrect product category codes.

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Food

Exporting Food to the United States from Southeast Asia: FDA Compliance for ASEAN Manufacturers

Apr 8, 2026

To export food to USA from Southeast Asia, ASEAN manufacturers must hold FDA facility registration, a DUNS number, a US Agent, and compliant labels.

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Food

What Is a UFI Number and How It Affects FDA Food Facility Registration

Apr 7, 2026

The UFI — Unique Facility Identifier — is the FDA's term for the identifier required in food facility registration. The DUNS number currently serves this role. Here is what foreign facilities need to know.

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Food

FDA Packaged Food Export Checklist: What Foreign Manufacturers Must Have Ready

Apr 6, 2026

A complete FDA packaged food export checklist covering registration, DUNS, US Agent, Prior Notice, and label compliance for foreign manufacturers.

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Food

What Is a US FDA Agent — And Why Every Foreign Food Facility Must Have One

Apr 5, 2026

A US FDA Agent for foreign facilities is mandatory under the Bioterrorism Act. Here is what the role covers and what happens without one.

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Food

What Is an FDA Food Facility Registration — And Why Every Foreign Manufacturer Needs One

Apr 4, 2026

FDA food facility registration is mandatory for foreign manufacturers shipping food to the US. Here is what it covers and what happens without it.

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Food

What Is a DUNS Number and Why Food Exporters Need One Before FDA Registration

Apr 3, 2026

A DUNS number for FDA registration is required before foreign food facilities can file. Here is what it is and what goes wrong.

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Food

What Documents to Prepare Before Starting FDA Food Facility Registration

Apr 3, 2026

Missing documents are the top reason FDA food facility registrations stall. Here is the complete checklist of what foreign manufacturers must have in hand before opening the FDA's registration system.

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Food

FDA Shell Egg Registration: What Egg Producers Outside the US Must Know

Apr 2, 2026

FDA shell egg producer registration has its own rules under 21 CFR Part 118. Foreign egg facilities face dual filing requirements.

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Food

Exporting Food to the United States from the Middle East: What You Need Before Your First Shipment

Apr 1, 2026

Export food to USA from Middle East? FDA registration, a US Agent, DUNS number, and label compliance are required before shipping.

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Food

FDA Export Certificates: When Foreign Manufacturers Need Them and How to Obtain Them

Mar 30, 2026

FDA export certificates confirm a facility's registration status and product compliance for foreign government import requirements. Here is what they cover, who issues them, and when they are needed.

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Food

FSMA Preventive Controls: What Foreign Food Manufacturers Must Include in Their Food Safety Plans

Mar 22, 2026

FSMA's Preventive Controls rule requires foreign food manufacturers exporting to the US to have documented food safety plans with hazard analysis, preventive controls, and monitoring procedures.

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Food

How to Get a DUNS Number for FDA Registration: A Step-by-Step Guide for Foreign Food Exporters

Mar 14, 2026

Getting a DUNS number is the first required step before FDA food facility registration. Here is exactly how foreign food manufacturers apply, what information is needed, and how long it takes.

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Food

How to Export Food from Vietnam to the USA: Complete FDA Guide

Mar 12, 2026

A practical checklist for Vietnamese food exporters preparing FDA filings, US Agent coverage, and label review before their first shipment.

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Food

How to keep your FDA food facility registration in good standing

Mar 10, 2026

What foreign food manufacturers need to know about keeping their FDA registration accurate, their US Agent active, and their shipments moving without delays.

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Food

DUNS Number FAQ for Foreign Food Exporters: Common Questions Before FDA Registration

Mar 10, 2026

Foreign food exporters have consistent questions about DUNS numbers before starting FDA registration. This FAQ addresses the most common ones — from cost to timing to multiple facilities.

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Food

What foreign food facilities should prepare before registration

Mar 8, 2026

The main company details and facility information you should have ready before you begin the filing process.

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Food

How to export packaged food to the USA for the first time

Mar 6, 2026

A plain-language starting guide for factories preparing their first FDA-related filings before shipping to America.

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Food

What Is an FEI Number and Why It Matters for Every FDA-Registered Facility

Mar 6, 2026

The FEI number — FDA Establishment Identifier — is the FDA's permanent identifier for every registered facility. It appears in import records, inspection reports, and FDA databases. Here is what it is and how it works.

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Food

How to start exporting packaged food to the USA

Mar 1, 2026

A simple overview of the first filings most food manufacturers need before shipping to the US market.

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Articles in foreign languages / Yabancı dilde makaleler / 外国語の記事 / Artículos en otros idiomas →

🇹🇷 Türkçe — Gıda ve Kozmetik İhracatı

FDA gıda tesisi kaydı, US Agent, DUNS numarası ve MoCRA kozmetik kaydı hakkında Türk ihracatçılara yönelik kapsamlı bilgiler.

🇩🇪 Deutsch — FDA-Registrierung für deutsche Exporteure

FDA Lebensmittelregistrierung, US Agent Pflicht, DUNS-Nummer und MoCRA-Kosmetikregistrierung für deutsche Exporteure.

🇫🇷 Français — Enregistrement FDA pour les exportateurs français

Enregistrement d'établissement alimentaire FDA, agent américain, numéro DUNS et enregistrement cosmétiques MoCRA pour les entreprises françaises exportant vers les États-Unis.

🇮🇹 Italiano — Registrazione FDA per esportatori italiani

Registrazione stabilimento alimentare FDA, US Agent, numero DUNS e registrazione cosmetici MoCRA per aziende italiane che esportano negli Stati Uniti.

🇷🇴 Română — Înregistrare FDA pentru exportatorii români

Înregistrare unitate alimentară FDA, Agent SUA, număr DUNS și înregistrare cosmetice MoCRA pentru companiile românești care exportă în Statele Unite.

🇵🇱 Polski — Rejestracja FDA dla polskich eksporterów

Rejestracja zakładu spożywczego FDA, US Agent, numer DUNS i rejestracja kosmetyków MoCRA dla polskich firm eksportujących do Stanów Zjednoczonych.

🇬🇷 Ελληνικά — Εγγραφή FDA για Έλληνες εξαγωγείς

Εγγραφή μονάδας τροφίμων FDA, US Agent, αριθμός DUNS και εγγραφή καλλυντικών MoCRA για ελληνικές εταιρείες που εξάγουν στις Ηνωμένες Πολιτείες.

🇨🇳 中文 — FDA注册服务

中国食品出口FDA注册、FDA化妆品注册(MoCRA)、DUNS编号申请、美国代理人服务。帮助中国制造商顺利进入美国市场。

🇯🇵 日本語 — FDA登録サービス

FDA食品施設登録、USエージェント指定、DUNS番号取得、化粧品MoCRA登録。日本からアメリカへの輸出をサポート。

🇰🇷 한국어 — 한국 수출업체를 위한 FDA 등록

FDA 식품 시설 등록, 미국 대리인(US Agent), DUNS 번호 취득, MoCRA 화장품 등록. 서울, 부산, 인천의 제조업체 지원.

🇻🇳 Tiếng Việt — Đăng ký FDA cho nhà xuất khẩu Việt Nam

Đăng ký cơ sở thực phẩm FDA, US Agent, số DUNS và đăng ký mỹ phẩm MoCRA dành cho nhà xuất khẩu Việt Nam.

🇹🇭 ภาษาไทย — FDA สำหรับผู้ส่งออกไทย

การลงทะเบียนสถานประกอบการอาหาร FDA, ตัวแทนสหรัฐ, หมายเลข DUNS และการลงทะเบียนเครื่องสำอาง MoCRA สำหรับผู้ผลิตไทย

🇲🇾 Bahasa Melayu — Pendaftaran FDA untuk pengeksport Malaysia

Pendaftaran kemudahan makanan FDA, Ejen AS, nombor DUNS dan pendaftaran kosmetik MoCRA untuk syarikat Malaysia yang mengeksport ke Amerika Syarikat.

🇮🇳 हिन्दी — भारतीय निर्यातकों के लिए FDA पंजीकरण

FDA खाद्य सुविधा पंजीकरण, US एजेंट, DUNS नंबर और MoCRA सौंदर्य प्रसाधन पंजीकरण। मुंबई, दिल्ली और बेंगलुरु के निर्माताओं के लिए सहायता।

🇮🇩 Bahasa Indonesia — Pendaftaran FDA untuk eksportir Indonesia

Pendaftaran fasilitas makanan FDA, Agen AS, nomor DUNS, dan pendaftaran kosmetik MoCRA untuk perusahaan Indonesia yang mengekspor ke Amerika Serikat.

🇧🇩 বাংলা — বাংলাদেশি রপ্তানিকারকদের জন্য FDA নিবন্ধন

FDA খাদ্য সুবিধা নিবন্ধন, US Agent, DUNS নম্বর এবং MoCRA কসমেটিক্স নিবন্ধন। ঢাকা, চট্টগ্রাম ও সিলেটের উৎপাদনকারীদের সহায়তা।

🇺🇿 O'zbekcha — O'zbek eksportchilar uchun FDA ro'yxatga olish

FDA oziq-ovqat korxonasini ro'yxatga olish, AQSh agenti, DUNS raqami va MoCRA kosmetika ro'yxatga olish. Toshkent va Samarqand ishlab chiqaruvchilariga yordam.

🇰🇪 Kiswahili — Usajili wa FDA kwa wasafirishaji wa Kenya

Usajili wa kiwanda cha chakula FDA, Wakala wa Marekani, nambari ya DUNS na usajili wa MoCRA. Kusaidia wazalishaji kutoka Nairobi na Mombasa.

🇪🇹 አማርኛ — ለኢትዮጵያ ወጪ ላኪዎች FDA ምዝገባ

FDA የምግብ ተቋም ምዝገባ፣ የአሜሪካ ወኪል፣ DUNS ቁጥር እና MoCRA ምዝገባ። ከአዲስ አበባ እና ድሬዳዋ ላሉ አምራቾች ድጋፍ።

🇸🇦🇦🇪🇪🇬🇲🇦 العربية — تسجيل FDA للمصدِّرين العرب

تسجيل منشأة الأغذية FDA، تعيين وكيل أمريكي، رقم DUNS، وتسجيل مستحضرات التجميل وفق قانون MoCRA للشركات العربية المصدِّرة إلى الولايات المتحدة.

🇵🇰 اردو — پاکستانی برآمد کنندگان کے لیے FDA رجسٹریشن

FDA فوڈ فیسیلیٹی رجسٹریشن، امریکی ایجنٹ، DUNS نمبر اور MoCRA کاسمیٹکس رجسٹریشن۔ کراچی، لاہور اور فیصل آباد کے مینوفیکچررز کی مدد۔

🇵🇭 Filipino — FDA registration para sa mga exporters ng Pilipinas

FDA food facility registration, US Agent, DUNS number at MoCRA cosmetics registration. Tulong sa mga tagagawa mula Maynila, Cebu at Davao.

🇲🇽🇨🇴🇦🇷🇵🇪 Español — Registro FDA para exportadores latinoamericanos

Registro de instalaciones alimentarias FDA, número DUNS, agente estadounidense y registro de cosméticos MoCRA. Servicio completo desde $449 USD.

🇧🇷 Português — Registro FDA para exportadores brasileiros

Registro de estabelecimento alimentar na FDA, US Agent, número DUNS e Registro de cosméticos MoCRA para empresas brasileiras exportando para os EUA.

🇿🇦🇳🇬🇬🇭 English (Africa) — FDA Registration for African Exporters

FDA food facility registration, US Agent, DUNS number and MoCRA cosmetics registration for African companies exporting to the United States.