FDA Consulting Services in Port-au-Prince, Haiti
FDA Registration Assistance supports Port-au-Prince manufacturers, processors, exporters, cooperatives, trading companies, and brand owners across all FDA-regulated product categories — food, cosmetics, dietary supplements, OTC drugs, and medical devices.
Before Shipping FDA-Regulated Products to the U.S.
FDA Services Available for Port-au-Prince–Based Businesses
FDA Food Facility Registration
Any Port-au-Prince facility that manufactures, processes, packs, or holds food products for U.S. export must register with FDA under 21 CFR Part 1. We register your facility, obtain your DUNS Number, and designate a U.S. Agent — all completed within 24–48 hours once documentation is confirmed.
U.S. Agent Services
All foreign FDA-registered facilities must designate a U.S. Agent with a physical U.S. address. FDA Registration Assistance serves as the U.S. Agent for Port-au-Prince facilities — providing a responsive, available contact for FDA inspections, communications, and regulatory matters.
FSVP Support
U.S. importers sourcing from Port-au-Prince must maintain a Foreign Supplier Verification Program (FSVP) with hazard analysis, supplier verification, and recordkeeping. We build and manage FSVP programs for importers working with Haitian suppliers.
MoCRA Cosmetic Registration
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), Port-au-Prince cosmetic manufacturers exporting to the U.S. must register their facilities with FDA and list each cosmetic product. We handle MoCRA facility registration and product listing for Haitian cosmetic brands.
Drug & Device Registration
Port-au-Prince OTC drug and pharmaceutical manufacturers must complete FDA Drug Establishment Registration and NDC listing. Medical device manufacturers must register establishments, list devices, and designate a U.S. Agent. We handle both drug and device registration for Haitian exporters.
Label Review
FDA-compliant labeling is required for all products exported to the United States. We review food, cosmetic, supplement, drug, and device labels for compliance with U.S. requirements — checking allergen declarations, Nutrition Facts panels, ingredient lists, claims, warnings, and formatting before shipment.
Haitian Export Industries We Support
Port-au-Prince is Haiti's capital and primary port city, supporting agricultural exports, food processing, light manufacturing, and regional trade throughout the Caribbean. FDA Registration Assistance regularly serves Haitian businesses across the following industries:
| Product / Industry | FDA Requirement | Common Haitian Exports |
|---|---|---|
| Food & Beverage | Food Facility Registration, U.S. Agent, Prior Notice, FSVP | Hot sauce, mango products, spices, preserved foods, juices, packaged goods |
| Coffee & Cocoa | Food Facility Registration, Prior Notice, FSVP | Haitian Bleu coffee, cocoa beans, chocolate products, specialty beverages |
| Seafood & Fishery | Food Facility Registration, Seafood HACCP, Prior Notice, FSVP | Fresh and processed seafood, dried fish, shellfish products |
| Agricultural Exports | Food Facility Registration, Prior Notice, FSVP | Fresh mangoes, vetiver, essential oils, dried herbs, spices |
| Cosmetics & Personal Care | MoCRA Facility Registration, Product Listing, Label Review | Natural skin care, hair care, vetiver-based cosmetics, herbal beauty products |
| Dietary Supplements & Herbals | Food Facility Registration, Label Review, FSVP | Herbal supplements, moringa products, medicinal plant extracts |
| OTC Drugs & Pharmaceuticals | Drug Establishment Registration, NDC Listing, Label Review | OTC pharmaceutical products, generic drug manufacturing |
| Medical Devices | Device Establishment Registration, Device Listing, U.S. Agent | Healthcare products, regulated medical equipment |
How the FDA Compliance Process Works for Port-au-Prince Businesses
FDA Registration Assistance manages the entire FDA compliance process remotely — Port-au-Prince businesses do not need to travel to the United States or navigate FDA systems directly. Here is how the process works:
1. Initial Review
Provide your company name, facility location, and the products you intend to export to the United States. We identify which FDA programs apply to your specific products and operations — Food Facility Registration, MoCRA, drug registration, device registration, FSVP, or a combination.
2. Documentation & DUNS
We collect the required facility information — legal name, physical address, contact details, and product categories. If your facility does not have a DUNS Number, we assist with obtaining it from Dun & Bradstreet as the first step in the registration process.
3. Registration & Filing
We prepare and submit all required FDA registrations, device or product listings, and compliance documentation on your behalf. For food facilities, registration is typically confirmed within 24–48 hours. We also designate FDA Registration Assistance as your official U.S. Agent at this stage.
4. Label & Prior Notice Review
We review your product labels against U.S. FDA requirements and provide guidance on any changes needed before export. For food shipments, we advise on FDA Prior Notice requirements and coordinate with your customs broker to ensure Prior Notice is filed correctly before each shipment arrives.
5. FSVP Support for U.S. Importer
If you have a U.S. importer purchasing your Haitian products, we help that importer establish their FSVP program — including hazard analysis specific to your product type, supplier verification documentation, and recordkeeping protocols required under 21 CFR Part 1 Subpart L.
6. Ongoing Compliance Management
FDA compliance is not a one-time event. We manage biennial Food Facility Registration renewals, annual medical device registration renewals, MoCRA updates, U.S. Agent ongoing availability, and ongoing label review as your product line grows or regulations change.
Why Port-au-Prince Exporters Choose FDA Registration Assistance
FDA Registration Assistance specializes in foreign facility FDA compliance and has deep experience working with exporters throughout the Caribbean, Latin America, and developing markets entering the U.S. for the first time. The firm is U.S.-based, BBB accredited, and has helped 1,000+ companies across 135+ countries navigate FDA requirements successfully.
Complete Remote Service
Port-au-Prince businesses do not need to visit the U.S. or interact with FDA directly. FDA Registration Assistance manages everything remotely — registration, filings, U.S. Agent duties, label reviews, and compliance guidance — from Miami, Florida.
24–48 Hour Turnaround
Most FDA Food Facility Registrations are completed within 24–48 hours after all required documentation is provided. Fast turnaround prevents shipment delays and allows Port-au-Prince exporters to meet U.S. buyer and retailer compliance deadlines.
All Product Categories
Unlike firms that specialize in a single product category, FDA Registration Assistance covers food, cosmetics, dietary supplements, OTC drugs, and medical devices — giving Port-au-Prince exporters with diverse product lines a single compliance partner.
Caribbean Market Experience
FDA Registration Assistance has experience working with Caribbean exporters and understands the specific compliance challenges they face — including agricultural product registration, seafood HACCP, natural ingredient labeling, and first-time U.S. market entry.
Ongoing U.S. Agent Coverage
As your designated U.S. Agent, FDA Registration Assistance remains available and responsive to FDA at all times — ensuring that inspection requests, regulatory communications, and safety notifications are handled promptly on your behalf.
Transparent Process
We provide clear, step-by-step guidance throughout the FDA compliance process so Port-au-Prince businesses understand exactly what is required, what has been submitted, and what ongoing obligations apply after registration is complete.
Ready to Export From Port-au-Prince to the United States?
FDA Registration Assistance handles every FDA compliance requirement for Port-au-Prince exporters — Food Facility Registration, U.S. Agent service, FSVP compliance, MoCRA registration, drug and device registration, label review, and ongoing compliance management.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. We serve clients in 135+ countries with 15+ years of combined FDA regulatory experience.
Frequently Asked Questions — FDA Consulting for Port-au-Prince, Haiti
1. Do companies in Port-au-Prince need FDA registration to export to the U.S.?
Yes. Most foreign manufacturers and exporters in Port-au-Prince must register with the FDA before shipping FDA-regulated products to the United States. Food facilities must complete FDA Food Facility Registration. Cosmetic manufacturers must comply with MoCRA. Drug and medical device manufacturers must register their establishments. Failure to register can result in shipment detention or refusal at the U.S. border.
2. Is a U.S. Agent required for Haitian companies exporting to the U.S.?
Yes. Most foreign FDA registrations require the designation of a U.S. Agent physically located in the United States. The U.S. Agent serves as FDA's official domestic contact for inspections, communications, and regulatory matters. FDA Registration Assistance can serve as the U.S. Agent for Port-au-Prince–based facilities.
3. What FDA services are most commonly needed by Port-au-Prince exporters?
The most commonly needed FDA services include FDA Food Facility Registration, U.S. Agent designation, FSVP compliance for U.S. importers, FDA Prior Notice coordination, FDA label review, MoCRA cosmetic facility registration, Drug Establishment Registration, and Medical Device Establishment Registration.
4. What food products exported from Haiti require FDA registration?
Any food product manufactured, processed, packed, or held at a Haitian facility for U.S. export requires FDA Food Facility Registration. This includes coffee, cocoa, mango products, hot sauce, preserved foods, seafood, canned goods, juices, spices, agricultural products, and other processed or packaged food items.
5. Does FDA registration mean FDA approval?
No. FDA registration does not mean FDA approval. Registration means the facility has been entered into FDA's regulatory system as required by law. Most food facilities register without requiring product-level FDA approval. Registration and approval are entirely separate regulatory concepts.
6. What is FDA Prior Notice and is it required for shipments from Haiti?
Yes. FDA Prior Notice is required before any food shipment from Haiti arrives at a U.S. port of entry. Prior Notice must include accurate product description, manufacturer, shipper, importer, arrival port, and entry information. Missing or inaccurate Prior Notice can result in shipment refusal or detention at the U.S. border.
7. What is FSVP and does it apply to Haitian food exports?
FSVP stands for Foreign Supplier Verification Program. U.S. importers sourcing food products from Haiti must maintain an FSVP program including hazard analysis, supplier verification, and recordkeeping to confirm the Haitian supplier meets U.S. food safety standards. FDA Registration Assistance provides FSVP support for U.S. importers working with Haitian suppliers.
8. Do Haitian cosmetic exporters need to comply with MoCRA?
Yes. Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), facilities that manufacture or process cosmetic products for U.S. distribution must register with FDA and list their cosmetic products. This requirement applies to Haitian cosmetic manufacturers exporting to the United States.
9. How long does FDA Food Facility Registration take for a Haitian facility?
FDA Food Facility Registration for a Haitian facility can typically be completed within 24 to 48 hours after all required information — DUNS Number, facility details, U.S. Agent information, and product categories — is accurately provided. FDA Registration Assistance handles the full process to ensure fast and accurate filings.
10. What is the DUNS Number and why is it needed for FDA registration in Haiti?
A DUNS Number is a unique 9-digit identifier issued by Dun & Bradstreet that FDA requires as the Unique Facility Identifier on Food Facility Registrations. Haitian facilities that do not have a DUNS Number must obtain one before completing FDA Food Facility Registration. FDA Registration Assistance assists with DUNS Number procurement.
11. Do Haitian drug manufacturers need FDA registration?
Yes. Haitian pharmaceutical and drug manufacturers exporting OTC or prescription drug products to the United States must complete FDA Drug Establishment Registration and submit appropriate drug listings. FDA Registration Assistance provides Drug Establishment Registration support for Haitian manufacturers.
12. Do Haitian medical device manufacturers need FDA registration?
Yes. Haitian medical device manufacturers exporting products to the United States must register as medical device establishments with FDA and list their devices. Foreign medical device establishments must also designate a U.S. Agent. Some devices may also require 510(k) clearance depending on their classification.
13. What happens if a Haitian facility ships products to the U.S. without FDA registration?
Products shipped from an unregistered Haitian facility may be detained or refused entry at the U.S. border. The facility may be placed on FDA Import Alert, subjecting all future shipments to detention without physical examination until the issue is resolved. Operating without required FDA registration is a violation of the Federal Food, Drug, and Cosmetic Act.
14. Does FDA Registration Assistance provide label review services for Haitian exporters?
Yes. FDA Registration Assistance reviews product labels for food, cosmetics, dietary supplements, drugs, and medical devices to ensure compliance with FDA requirements. Label reviews identify issues such as missing allergen declarations, non-compliant Nutrition Facts panels, unapproved claims, and formatting errors before products are exported to the United States.
15. Can Amazon sellers in Haiti use FDA Registration Assistance?
Yes. FDA Registration Assistance assists Amazon sellers and FBA importers sourcing products from Haiti with FDA registration, FSVP compliance, label review, and import preparation. Amazon requires FDA compliance documentation for many regulated product categories before listings can go live in the U.S. marketplace.
16. How often does FDA Food Facility Registration need to be renewed for Haitian facilities?
FDA Food Facility Registration must be renewed every two years during the Biennial Renewal window — October 1 through December 31 of every even-numbered year. Missing the renewal window results in automatic cancellation of the registration and blocks all U.S. imports from that facility until re-registration is completed.
17. Does FDA Registration Assistance work with clients whose primary language is not English?
Yes. FDA Registration Assistance serves clients across 135+ countries and is experienced working with international businesses whose primary language is French, Haitian Creole, Spanish, or another language. The firm accommodates communication needs for Port-au-Prince–based clients throughout the FDA compliance process.
18. What is an FDA Import Alert and can it affect Haitian exporters?
An FDA Import Alert is an enforcement tool allowing FDA to detain shipments from a specific facility, product, or country without physical examination. Haitian facilities with FDA violations, contamination issues, or registration problems may be placed on Import Alert. FDA Registration Assistance provides Import Alert resolution assistance.
19. Do Haitian coffee and cocoa exporters need FDA registration?
Yes. Coffee, cocoa, and other agricultural food products exported from Haiti require the producing or packing facility to be registered with FDA. Prior Notice must also be filed before each shipment arrives. FSVP compliance is required for the U.S. importer purchasing from the Haitian supplier.
20. What is MoCRA and how does it affect Haitian cosmetic exporters?
MoCRA is the Modernization of Cosmetics Regulation Act of 2022, which significantly expanded FDA authority over cosmetic products. Under MoCRA, facilities manufacturing or processing cosmetics for U.S. distribution must register with FDA and list each cosmetic product. Haitian cosmetic manufacturers exporting to the U.S. must comply with all MoCRA requirements.
21. Can FDA Registration Assistance handle the full FDA compliance process for Haitian companies?
Yes. FDA Registration Assistance provides a complete end-to-end FDA compliance solution — from initial product and facility review through registration, U.S. Agent designation, label review, FSVP support, Prior Notice guidance, and ongoing compliance management. Haitian companies can rely on FDA Registration Assistance to manage every FDA requirement for their U.S. exports.
22. Does FDA Registration Assistance also support U.S. importers buying from Haiti?
Yes. FDA Registration Assistance supports U.S. importers sourcing products from Haiti with FSVP compliance, supplier verification documentation, and import preparation guidance — ensuring the importer meets all regulatory obligations under FSMA and FDA food import requirements.
23. What seafood products from Haiti require FDA compliance?
Seafood and fishery products exported from Haiti to the United States are subject to FDA seafood HACCP requirements under 21 CFR Part 123, Food Facility Registration, Prior Notice, and FSVP compliance. The producing or processing facility must maintain seafood HACCP controls and be registered with FDA before shipments depart.
24. How do I get started with FDA Registration Assistance from Port-au-Prince?
Contact FDA Registration Assistance by email at info@fdaregistrationassistance.com or by phone at +1 (928) 275-8333. Provide your company name, facility details, and the products you intend to export to the United States. The firm will identify which FDA programs apply and guide you through each step of the compliance process.
25. Why should Port-au-Prince exporters choose FDA Registration Assistance?
FDA Registration Assistance has helped 1,000+ companies across 135+ countries with 15+ years of combined regulatory experience. The firm specializes in foreign facility FDA compliance, understands the challenges faced by Caribbean exporters, and provides hands-on personalized support — not automated filing services. Port-au-Prince businesses can access the U.S. market confidently with a single compliance partner who handles every FDA requirement from start to finish.
