ITB HOLDINGS LLC

ITB HOLDINGS LLC FDA REGISTRATION : Food Facility, Dietary Supplements, Food Canning, Alcoholic Beverage, Medical Device, Drugs, Cosmetics.

Contact ITB HOLDINGS LLC, Monday - Sunday, should you have any question or comment. ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States

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FDA REGISTRATION -

Foods | Canned Foods | Dietary Supplements | Medical Devices | Medical Apps | Prescription Drugs | Over-the-Counter (OTC) Drugs | Active Pharmaceutical Ingredients (APIs) | Cosmetics | Radiation-Emitting Products | Vaccines, Blood & Biologics | Animal & Veterinary Products | To***co Products. FDA SERVICES

US Agent (Foreign Companies)
Prior Notice (PN)
Label Review
FSVP. CONTACT

https://www.m.itbhdg.com | https://www.fda.itbhdg.com | https://www.itbhdg.com
T : +1 855 510 2240 | T : +1 855 389 7344 | T : +44 800 610 1577 (3:00 AM - 6:00 PM Eastern Standard Time)
Skype: itbholdings

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09/05/2026

Renouvellement FDA : Le Guide Essentiel

Vous dirigez une entreprise agroalimentaire en France ou en Belgique ? Vous exportez des cosmétiques ou des dispositifs médicaux depuis la Suisse, le Canada ou l’Afrique de l'Ouest vers les États-Unis ? Attention : vos conteneurs risquent d'être bloqués à la douane américaine du jour au lendemain pour une simple formalité administrative oubliée.

Dans cette vidéo, nous passons au crible tout ce que les entreprises francophones doivent savoir : les dates limites fatidiques, les exigences par industrie, et la méthode pas-à-pas pour sécuriser vos exportations sans stress. Restez bien jusqu'à la fin pour éviter les erreurs qui coûtent des milliers de dollars.

https://youtube.com/shorts/0QQVgHqP0B0

https://www.fda.itbhdg.com/enregistrement-fda/

08/24/2026

【完全保存版】Amazon FBAを活用して米国で日本食品を販売する最短ステップ!

米国(アメリカ)マーケットでの日本食品の需要は年々高まっています。本動画では、日本の魅力的な食品や特産品を Amazon FBA(Fulfillment by Amazon)を利用して、最も効率的かつスピーディーにアメリカ市場へ届ける方法を徹底解説します!

アカウントの開設手順から FDA(米国食品医薬品局)規制への対応、効率的なロジスティクス、現地顧客を惹きつける商品ページ作成のコツまで、初心者にも分かりやすくまとめています。個人事業主や地方の食品メーカー様、海外輸出に挑戦したいEC事業者様は必見の内容です。

📌 タイムスタンプ
オープニング:米国における日本食品需要の現状
なぜ Amazon FBA を活用すべきなのか?
必須知識!FDA規制・食品安全基準とラベル表示規則
米国 Amazon セラーアカウントの開設と設定手順
FBA倉庫への納品フローと国際物流の最適化
成功する現地向けリスティング&商品ページの作成術
初心者によくあるミスと回避策
まとめ&最初のアクションステップ

https://www.youtube.com/watch?v=hzUhuzHwVxQ

https://www.itbholdingsllc.com/日本の製造業者または輸出業者に対する米国fdaの/

#日本食品輸出 #海外販売 #物販ビジネス #海外展開

08/04/2026

FDA Compliance for Acidified & Low-Acid Canned Foods

Master FDA compliance for low-acid canned foods (LACF) and acidified foods! If you manufacture, process, or pack food products destined for the U.S. market, navigating Food Canning Establishment (FCE) registration and Submission Identifier (SID) filings is essential to avoid costly import delays and detention.

In this video, we break down the step-by-step process for both domestic and foreign facilities looking to sell in the U.S. Learn how FCE registration works, why Scheduled Process (SID) filings are mandatory, and how specialized FDA compliance consultants can help streamline your filings for seamless market entry.

https://www.youtube.com/watch?v=bWqag-gu4gE

https://www.itbholdingsllc.com/services/fce-sid/

07/25/2026

FDA U.S. Agent Explained in Seconds!

🔍 Did you know? If you're a foreign manufacturer exporting food, drugs, medical devices, or cosmetics to the United States, the FDA requires you to designate a U.S. Agent before your products can legally enter the market!

In this Short, we break down:
✅ What a U.S. Agent is
✅ Who needs one (hint: ALL foreign facilities!)
✅ Key responsibilities of a U.S. Agent
✅ How to designate one
✅ What happens if you DON'T have one

🚫 No U.S. Agent = No FDA Registration = No U.S. Market Access!

💡 Don't risk your products being refused at the U.S. border!

👉 FOLLOW for more FDA compliance tips every week!
💬 COMMENT below: Are you a foreign manufacturer trying to enter the U.S. market? What's your biggest FDA challenge?
👍 LIKE this video if you found it helpful!

https://youtube.com/shorts/mZwRq5pJaPM

https://www.fda.itbhdg.com/u-s-agent/

07/22/2026

Une entreprise étrangère comme Importateur (IOR) aux États-Unis

Une entreprise étrangère peut-elle être l’importateur officiel (IOR) aux États-Unis sans présence locale ? Découvrez les règles 2026 pour l’Europe, le Canada et ailleurs : numéro CBP, caution douanière, agent résident et conformité.

Regardez notre vidéo YouTube pour un guide pas à pas : comment devenir IOR aux USA sans filiale américaine et éviter les blocages en douane.

https://www.youtube.com/watch?v=_SFfbOv3pQo

https://www.itbholdingsllc.com/enregistrement-fda/

07/16/2026

Foreign Company as U.S. Importer of Record (IOR)

Are you a foreign manufacturer or exporter shipping FDA-regulated products to the United States? Understanding how to become a U.S. Importer of Record (IOR) is essential for smooth customs clearance, FDA compliance, and avoiding costly shipment delays.

In this video, we explain how overseas companies can act as an Importer of Record, what documents are required, why customs bonds and broker support matter, and how to prepare FDA-regulated shipments for entry into the U.S. market.

📋 WHAT YOU'LL LEARN:

✅ What is a U.S. Importer of Record (IOR) and why it's required
✅ Why foreign companies can't directly serve as IOR
✅ 3 proven pathways for foreign manufacturers to import FDA products
✅ FDA Initial Importer requirements for medical devices
✅ How to establish a U.S. entity for import operations
✅ Essential FDA registration and compliance requirements
✅ Common mistakes that cause customs delays and FDA detentions
✅ Documentation checklist for seamless port entry
✅ Customs bond requirements and entry filing process
✅ Difference between customs broker and Importer of Record

Whether you ship food, dietary supplements, cosmetics, medical devices, drugs, or other FDA-regulated goods, proper IOR setup and import compliance planning can help protect your supply chain and keep your products moving.

Need help setting up as a U.S. Importer of Record or preparing your FDA-regulated shipments for customs clearance? Contact our import compliance experts today to get started.

🔔 Don’t forget to like this video, subscribe to our channel, and turn on notifications for more tips on FDA compliance, U.S. imports, customs clearance, and global trade.

🙏 Thank you for watching! Your success in U.S. markets matters to us. Let's make your FDA import journey smooth and compliant.

https://www.youtube.com/watch?v=OwBtudARO-0

https://www.fda.itbhdg.com/foreign-company-as-u-s-ior/

07/13/2026

Advancing U.S. Drug Manufacturing

7 companies have been fast-tracked to participate in the FDA PreCheck Pilot Program—and this could be a major move for the future of American pharmaceutical manufacturing. In this Short, we break down what the FDA PreCheck Pilot Program means, why it matters for the drug supply chain, and how it could impact speed, safety, and innovation in the U.S. pharma industry.

Stay updated on FDA news, drug manufacturing, biotech, pharmaceutical policy, and U.S. healthcare innovation.

👉 Like, comment, and subscribe for more quick updates on FDA developments, biotech news, and the future of U.S. manufacturing.

https://youtube.com/shorts/3P9gZVqK9HU

https://www.itbholdingsllc.com/drug/

07/12/2026

U.S. Initial Importer Service

Unlock seamless entry into the U.S. medical device market with expert Initial Importer Services for foreign manufacturers. As a foreign company, navigating FDA regulations for medical device importation can be complex—but our specialized Initial Importer team handles everything from FDA registration and listing to compliance, labeling, and post-market reporting.

Whether you're a foreign medical device manufacturer seeking a reliable U.S. agent or need full-service support for importing Class I, II, or III devices, we ensure your products meet all FDA requirements efficiently and cost-effectively.

Why choose our U.S. Initial Importer services?
- Expert FDA regulatory guidance tailored for foreign manufacturers
- Streamlined importation process for medical devices
- Full compliance with 21 CFR Part 803, 807, and 820
- Ongoing support for adverse event reporting and recalls

Ready to expand your medical device business into the U.S.? Let our experienced team act as your trusted U.S. Initial Importer.

👉 Visit the link in the description or comment below to learn how we can help your foreign medical devices reach the American market faster. Don’t forget to like, subscribe, and hit the bell icon for more regulatory tips!

https://www.youtube.com/watch?v=ptie_S48Yz4

https://www.itbholdingsllc.com/initial-importer-service/

07/05/2026

米国FDAへの対応完全ガイド|日本の製造業者・輸出業者必見!

この動画では、米国市場へ製品を輸出する日本の製造業者や輸出業者の皆様に向けて、FDA(米国食品医薬品局)の規制要件について詳しく解説します。

🔍 この動画で学べること:
- FDA登録の基本手続きと必要書類
- 製品カテゴリー別の規制要件
- 食品・医薬品・医療機器・化粧品の輸出基準
- よくある間違いと対策方法
- 最新の規制アップデート情報
- コンプライアンス遵守のポイント

米国への輸出を成功させるために、FDA規制を正しく理解することが重要です。初めて米国市場に参入される方から、既存の輸出業務を見直したい方まで、実務に役立つ情報をわかりやすくお届けします。

✅ チャンネル登録 をして最新の貿易・規制情報をチェック!
👍 この動画が役立ったら 高評価 をお願いします
💬 ご質問やご相談は コメント欄 でお気軽にどうぞ
🔔 通知ベル をオンにして新着動画を見逃さない
📤 同じ悩みを持つ方に シェア してください

🎁 無料ダウンロード資料:FDA登録チェックリストは概要欄のリンクから!

https://www.youtube.com/watch?v=4w_uvdw2x2A

https://www.itbholdingsllc.com/日本の製造業者または輸出業者に対する米国fdaの/

07/03/2026

🛑 U.S. FDA COMPLIANCE: DEAL OR NO DEAL? That’s the question!

Don’t risk your next shipment, launch, or FDA deadline. Work with experienced FDA consultants and get compliant — fast.

✅ Avoid costly delays
✅ Grow globally with confidence
✅ Reduced service fees available now

We help domestic & foreign companies with:
• FDA Establishment & Facility Registration
• Product Listing
• FDA Labeling Requirements
• Application Filing
• Import Compliance
• Foreign Supplier Verification Program (FSVP)
• Inspection Readiness
• U.S. Market Entry

Trusted by thousands of clients in over 100 countries. Millions of American customers are ready to buy your products.

That’s the good news. Now the question is… What are you going to do?

Comment “DEAL” 👇 if you’re ready to get FDA compliant or “NO DEAL” if you’re still gambling.

Get expert help before your next FDA deadline 👉 Link below.

https://youtube.com/shorts/Zxe9qtKqvf4

https://www.fda.itbhdg.com/blog/fda-registration-deals/

Address

390 N Orange Avenue, Ste 2300
Orlando, FL
32801

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