FDA Consulting Services in Córdoba, Argentina
Trusted by 1,000+ companies across 135+ countries, with 15+ years of FDA regulatory experience. As a U.S.-based firm, we help Córdoba peanut, grain, oilseed, and food exporters register with the FDA and reach the U.S. market — and we can serve as your U.S. Agent.
FDA Services for Córdoba Exporters
Food & Agriculture
Peanuts, peanut butter & oil, grains, and oilseeds. Foreign food facility registration, aflatoxin & allergen review, U.S. Agent, and FSVP.
Drugs & Pharma
Córdoba's science and pharma base. Foreign drug establishment registration, listing, NDC labeler codes, DMF, and a U.S. Agent.
Medical Devices
Device and medical-product exporters. Foreign device registration, listing, the QMSR, U.S. Agent, and 510(k) context.
Cosmetics & Wellness
Personal-care and supplement exporters. MoCRA cosmetic registration, product listing, a Responsible Person, and safety.
Aflatoxin, Allergen, or Salmonella?
Peanuts register like other foods — but three hazards decide whether the shipment clears. Each one has its own control, and the FDA looks for all three.
| Hazard | Where it shows up | What the FDA expects |
|---|---|---|
| Aflatoxin | Raw & stored peanuts | Drying, sorting & lot testing within limits |
| Peanut allergen | All peanut products | Clear declaration & cross-contact control |
| Salmonella | Peanut butter & paste | Process controls & environmental monitoring |
| Pesticide residues | Field crops | Within U.S. tolerances |
Aflatoxin and undeclared allergens are the classic reasons peanut shipments get held. We help you align lot testing, drying and storage records, allergen labeling and cross-contact controls, and — for peanut butter and paste — Salmonella preventive controls, so your peanuts and grains clear U.S. review the first time.
Argentina's Peanut Heartland, Cleared for the U.S.
Córdoba — known as “la Docta,” home to Argentina's oldest university — sits at the center of the country's agro-industry, and above all it is Argentina's peanut heartland, producing roughly 90% of the nation's peanuts and anchoring the world's leading peanut-export sector, alongside soybeans, corn, wheat, and dairy.
Reaching the U.S. market means the processing or packing facility registers with the FDA, appoints a U.S. Agent, and clears the hazards that matter for these foods: aflatoxin testing, the peanut allergen, and Salmonella controls for peanut butter and paste — while the U.S. importer handles FSVP and Prior Notice. Córdoba's strong science and pharmaceutical base brings drug and device exporters into scope too. We're a U.S.-based firm serving Córdoba exporters across every FDA-regulated category.
A Step-by-Step Checklist
FDA Registration for Every Product Type
Whatever you export from Córdoba, we handle the full FDA pathway by category: FDA food facility registration, FDA drug establishment registration, medical device registration, and MoCRA cosmetic registration — with U.S. Agent services for each. Tell us your category and role, and we'll map the exact steps.
FDA Compliance for Your Córdoba Exports
Tell us your facility and products — peanuts, peanut butter or oil, grains, oilseeds, supplements, cosmetics, or other goods — and we'll confirm exactly which FDA registrations and listings apply, review your aflatoxin, allergen, and label records, appoint your U.S. Agent, and coordinate FSVP and Prior Notice with your importer. Email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
Frequently Asked Questions — FDA Consulting in Córdoba, Argentina
Do companies in Córdoba need FDA registration to sell in the U.S.?
Many do. If your Córdoba business produces, processes, packs, or holds FDA-regulated peanuts, foods, supplements, cosmetics, drugs, or devices intended for the U.S. market, the foreign facility generally must register with the FDA. What you file depends on the product.
What makes Córdoba distinctive for FDA compliance?
Córdoba is the heart of Argentina's agro-industry and the country's peanut powerhouse, producing most of its peanuts. So the FDA work here centers on peanuts — aflatoxin testing, the peanut allergen, and Salmonella controls for peanut butter and paste — alongside grains and oilseeds.
Is a U.S. Agent required for an Argentine exporter?
Yes. Every foreign facility that registers with the FDA must appoint a U.S. Agent located in the United States to serve as the FDA's contact. FDA Registration Assistance can act as your U.S. Agent.
How does a foreign food facility register with the FDA?
The facility submits a foreign food facility registration through the FDA's system, obtains a DUNS Number as its Unique Facility Identifier, and appoints a U.S. Agent. We prepare and submit the registration and maintain it through each renewal.
How does the FDA treat peanut exports?
Peanuts and peanut products — raw peanuts, blanched peanuts, peanut butter, paste, and oil — are foods, so the processor or packer registers as a foreign food facility, controls safety, and labels correctly. Córdoba's peanut exporters are squarely within scope.
What is the FDA's main concern with peanuts?
Aflatoxin. Peanuts can develop aflatoxin, a mold toxin, if grown, dried, or stored poorly, and the FDA screens peanut imports for it. Good drying, storage, sorting, and testing keep levels within U.S. limits, and we help you document those controls.
How is aflatoxin kept under control?
Through field practices, prompt drying to safe moisture, careful storage, color and defect sorting, and laboratory testing of lots before shipment. We help you align your testing and records with U.S. expectations and your importer's verification.
Is the peanut allergen a labeling issue?
Yes. Peanuts are one of the major U.S. allergens and must be declared clearly. Just as important, facilities that also handle other foods need cross-contact controls so peanut residue doesn't end up in products that don't declare it. We review labels and allergen controls.
We make peanut butter or paste — is there an added concern?
Yes. Salmonella in peanut butter and paste has caused serious U.S. recalls, so these low-moisture foods need process controls and environmental monitoring. We help you build preventive controls that address Salmonella and meet U.S. food-safety rules.
Does peanut oil have its own requirements?
Peanut oil is a food and registers like other foods, with attention to processing and labeling. Highly refined peanut oil is treated differently from cold-pressed for allergen purposes, so we confirm how your oil should be handled and declared.
Do soybeans, corn, and wheat exporters register too?
Yes. Grain and oilseed processors register as foreign food facilities, and soy is itself a major U.S. allergen requiring declaration. We map registration, labeling, and any allergen controls for your full agro-industrial product line.
What is FSVP, and who is responsible for it?
The Foreign Supplier Verification Program is the U.S. importer's responsibility — they verify that you, the foreign supplier, meet U.S. safety standards. We support both sides: your registration and documentation, and the importer's FSVP, so shipments clear.
What is Prior Notice?
Prior Notice is an electronic notice filed with the FDA before each food shipment arrives in the U.S. It's usually handled on the U.S. side, and we coordinate it with your importer so peanut and grain shipments aren't held at the port of entry.
What happens if a shipment doesn't comply at the U.S. border?
The FDA can refuse admission, detain the shipment, or place it on an import alert, and goods may be re-exported or destroyed. For peanuts, aflatoxin findings and undeclared allergens are common triggers, so testing, labeling, and records before shipment are essential.
Do dairy or processed-food exporters from Córdoba register?
Yes. Dairy, confectionery, and other processed foods register as foreign food facilities, label to U.S. rules, and meet safety standards. We handle whatever mix of products your facility exports.
Do labels need to change for the U.S. market?
Usually, yes. U.S. labels must be in English, with a Nutrition Facts panel, an ingredient list, allergen declarations, net quantity, and accurate claims. We review and correct labels so products aren't refused for misbranding.
Do dietary supplement exporters register?
Yes. Supplements, including botanical or herbal products, are regulated as foods, so the facility registers and follows U.S. cGMP under Part 111 with a Supplement Facts label and carefully worded claims. We handle the registration and U.S. Agent.
Do cosmetics and personal-care exporters register?
Under MoCRA, the foreign cosmetic manufacturer registers its facility, lists products, names a Responsible Person, and substantiates safety. Córdoba personal-care exporters are within scope.
Córdoba has a strong science and pharma base — do drug makers register?
Yes. Foreign drug establishments register and list with the FDA, appoint a U.S. Agent, follow cGMP, use NDC labeler codes, and file a Drug Master File for active ingredients. We map the requirements for Argentine pharmaceutical exporters.
Do medical device exporters from Argentina register?
Yes. Foreign device establishments register and list with the FDA, appoint a U.S. Agent, follow the QMSR, and use the right pathway, such as a 510(k) where required. We map the requirements for any Argentine device exporter.
We're a cooperative or trading company, not the grower — what do we register?
The facility that processes, blanches, mills, packs, or holds the peanuts or grain generally registers. Cooperatives, processors, and exporters may each have a role, and we sort out who registers and who serves as U.S. Agent so the chain is complete.
Does FDA registration mean our product is FDA approved?
No. Registration and listing are mandatory steps that let you enter the U.S. market; they are not FDA approval or endorsement. Claiming “FDA approved” when you are only registered is itself a violation.
Is FDA registration the same as meeting customs and trade rules?
No. FDA registration is separate from, and in addition to, U.S. customs, import, and other applicable trade laws. We handle the FDA side; your importer and customs broker handle entry and any other requirements.
Does our registration renew, and is a DUNS Number required?
Yes to both. Foreign food and cosmetic facility registrations renew biennially, while drug and device registrations renew annually, and food facility registration requires a DUNS Number as the Unique Facility Identifier. We obtain the DUNS and manage your renewals so your market access doesn't lapse.
How do I get started?
Send us your facility and product details — peanuts, peanut butter or oil, grains, oilseeds, supplements, cosmetics, or other products. Contact our team and we'll confirm which FDA requirements apply to your Córdoba business, review your aflatoxin, allergen, and label records, and handle the registration, U.S. Agent appointment, and filings. Email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
