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FDA Compliance
Navigate U.S. FDA Regulations with Confidence
If you’re a Vietnamese manufacturer or exporter planning to sell food, cosmetics, pharmaceuticals, dietary supplements, or medical devices in the United States, compliance with the U.S. Food and Drug Administration (FDA) is a critical step. Failure to meet FDA regulations can result in shipment delays, product recalls, legal penalties, and even bans on your products.
Our FDA Compliance Service helps Vietnamese sellers ensure their products meet all necessary regulations before export, reducing risks and improving market access. We provide end-to-end support, from registration and labeling to testing and certification, so your products can enter the U.S. market without complications.
Why FDA Compliance is Essential for U.S. Market Entry
The FDA regulates a wide range of products, including:
• Food & Beverages – Processed foods, fresh produce, seafood, dairy, meat substitutes, beverages, and supplements.
• Cosmetics & Personal Care Products – Skincare, hair care, makeup, and other beauty products.
• Pharmaceuticals & Over-the-Counter (OTC) Drugs – Prescription medications, pain relievers, supplements with medicinal claims.
• Medical Devices – Equipment, diagnostic tools, and healthcare-related technology.
• Dietary Supplements – Herbal extracts, vitamins, protein powders, and functional food products.
To legally import and sell these products in the U.S., businesses must comply with strict FDA regulations covering:
• Manufacturing standards (Good Manufacturing Practices - GMP)
• Product registration and listing requirements
• Ingredient and safety standards
• Labeling and packaging compliance
• Testing and certification procedures
Our team specializes in guiding Vietnamese sellers through these complex requirements, ensuring your products are fully compliant before they reach U.S. consumers.
Our FDA Compliance Services
1. FDA Registration & Product Listing
All foreign food, cosmetic, drug, and medical device manufacturers must register with the FDA before exporting to the U.S. We assist with:
• Registering your manufacturing facility with the FDA.
• Assigning a U.S. Agent (required for all foreign businesses).
• Submitting product listings for compliance verification.
• Renewing registrations to maintain compliance.
2. Labeling & Packaging Compliance
Improper labeling is one of the leading causes of product rejections at U.S. ports. We ensure that your packaging meets all FDA labeling rules, including:
• Food Labeling – Nutrition facts, allergen warnings, ingredient lists, and country of origin.
• Cosmetic Labeling – Required ingredient disclosure, usage instructions, and warning statements.
• Pharmaceutical & Supplement Labeling – Dosage information, health claims, and drug facts panels.
• Medical Device Labeling – Unique Device Identifier (UDI), safety warnings, and usage instructions.
Our experts review your labels and provide corrective recommendations before you begin exporting.
3. Product Testing & Safety Certification
Certain products, especially food, cosmetics, pharmaceuticals, and medical devices, must undergo FDA-approved testing to confirm they are safe for U.S. consumers. We help with:
• Food safety testing – Checking for contaminants, pesticide residues, and microbiological safety.
• Cosmetic product testing – Ensuring non-toxic ingredients and allergen compliance.
• Pharmaceutical & supplement analysis – Verifying potency, purity, and ingredient authenticity.
• Medical device testing – Assessing performance, sterility, and biocompatibility.
We connect you with certified U.S. laboratories that conduct these tests according to FDA standards.
4. Pre-Import Compliance Review
Before you ship your products to the U.S., we conduct a pre-import compliance review to:
• Ensure all FDA documents are correctly submitted.
• Verify that product labels and packaging meet regulations.
• Identify potential compliance risks that could lead to shipment delays or rejections.
This step prevents costly mistakes and ensures your shipments clear customs smoothly.
5. FDA Inspections & Audits Support
FDA inspections can occur before or after your product reaches the U.S. market. If the FDA requires an audit of your manufacturing facility or processes, we help you:
• Prepare all required documentation for FDA inspections.
• Implement Good Manufacturing Practices (GMP) to meet FDA quality standards.
• Address FDA concerns and ensure your facility passes compliance checks.
If your shipment is detained for non-compliance, we also assist with corrective actions and re-submissions.
Why Choose Us for FDA Compliance?
• Industry-Specific Expertise – Whether you manufacture food, cosmetics, pharmaceuticals, or medical devices, our team understands the specific FDA requirements for your industry.
• End-to-End Support – From registration to final approval, we manage the entire compliance process for you.
• Avoid Costly Delays – We help you prevent shipment rejections, customs holds, and expensive penalties by ensuring full compliance before export.
• Strong Network of Compliance Experts – We work with certified FDA consultants, laboratories, and legal advisors to ensure your business meets U.S. standards.
Get Started with FDA Compliance Today
If you’re exporting products from Vietnam to the U.S., ensuring FDA compliance is not optional—it’s essential. Don’t let regulatory hurdles slow down your business.
Contact us today for a consultation and let our experts guide you through the FDA approval process. We’ll help you get your products on U.S. shelves faster, safer, and fully compliant!