FOOD AND BEVERAGE
From facility registration to labeling, Foreign Supplier Verification Program (FSVP), and inspection readiness, we provide end-to-end FDA compliance support for food and beverage companies, helping you enter the U.S. market smoothly and stay compliant long term.
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FDA COMPLIANCE FOR EXPORTERS TO THE U.S.
We help international manufacturers and brand owners meet all FDA requirements before entering the U.S. market—reducing delays, refusals, and costly enforcement actions at the border.
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REGISTER A FOOD FACILITY
FDA food facility registration is mandatory for all domestic and foreign facilities that manufacture, process, pack, or hold food for U.S. consumption. We handle the full registration process accurately and efficiently.
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REGISTER A SUPPLEMENT FACILITY
Dietary supplement manufacturers and packers must comply with FDA registration and cGMP obligations. We ensure your facility is properly registered and aligned with U.S. supplement regulations.
REGISTER A FOOD CANNING ESTABLISHMENT (FCE)
Low-acid and acidified food producers must register their facility and processes with the FDA. We manage FCE registration and process filings to prevent serious compliance violations.
MEET FSVP REQUIREMENTS
U.S. importers are legally responsible for verifying that foreign suppliers meet FDA safety standards. We build and maintain compliant Foreign Supplier Verification Programs tailored to your products and risk profile.
UPDATE YOUR PACKAGING & LABEL
FDA labeling errors are a leading cause of import refusals and recalls. We review and update your packaging and labels to ensure accuracy, compliance, and claim substantiation.
OBTAIN FDA ESTABLISHMENT IDENTIFIER (FEI) NUMBER
An FEI number is required for FDA inspections and regulatory tracking. We assist in obtaining or verifying your FEI to ensure your facility is properly recognized by the FDA.
FILE A PRIOR NOTICE
All FDA-regulated food products must be reported to the FDA before arriving in the U.S. We prepare and submit accurate Prior Notices to avoid shipment holds or refusals
PREPARE FOR AN INSPECTION
FDA inspections can happen without notice and carry serious consequences. We prepare your facility, staff, and documentation to confidently pass inspections and avoid Form 483s or enforcement actions.
PAY FOR YOUR SERVICES
Securely submit your service fees to initiate or continue your FDA compliance services. Transparent pricing and prompt processing ensure your project moves forward without delays.
TRAINING TO STAY COMPLIANT
Ongoing compliance requires knowledgeable teams. Our FDA training programs equip your staff with practical, up-to-date regulatory knowledge to prevent violations, reduce risk, and maintain long-term compliance.
FREE COMPLIANCE TOOLS
Access practical FDA compliance tools, checklists, and resources designed to help you identify gaps, stay organized, and reduce regulatory risk—at no cost.
Conventional Food
Conventional foods include most everyday food products sold for human consumption. These products must comply with FDA requirements for facility registration, labeling compliance, preventive controls, and manufacturing standards.
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Dietary Supplement
Dietary supplements include vitamins, minerals, herbs, and nutritional products. Facilities must meet FDA labeling requirements, ingredient disclosure rules, and comply with dietary supplement GMP regulations.
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Canned Food (FCE)
Shelf-stable canned foods require additional FDA oversight. Facilities must register as Food Canning Establishments (FCE) and file scheduled processes to ensure thermal processing safety compliance.
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Food Facility U.S. Agent
Helping food and beverage manufacturers navigate FSMA, FSVP, and FDA facility registration.
1. What is a Food U.S. Agent?
A mandatory contact person located in the U.S. for foreign food facilities to communicate with the FDA.
2. What is FSMA?
The Food Safety Modernization Act shifts the focus from responding to foodborne illness to preventing it.
3. Is facility registration biennial?
Yes, all food facilities must renew their FDA registration between Oct 1 and Dec 31 of every even-numbered year.
4. What is a PCQI?
A Preventive Controls Qualified Individual who oversees the facility's Food Safety Plan.
5. What is an FSVP?
The Foreign Supplier Verification Program requires importers to verify that foreign suppliers meet U.S. safety standards.
6. Does FDA approve labels?
FDA does not "approve" labels before marketing, but they must comply with strict format and disclosure rules.
7. What is a Food Safety Plan?
A written document including hazard analysis, preventive controls, and corrective action procedures.
8. What are HARPC requirements?
Hazard Analysis and Risk-Based Preventive Controls, the core safety framework under FSMA.
9. What is the DUNS number?
A unique 9-digit identifier required by the FDA for facility registration and FSVP compliance.
10. What is LACF?
Low-Acid Canned Foods have specific processing and filing requirements (FCE/SID) to prevent botulism.
11. What is Prior Notice?
A mandatory notification to the FDA for every shipment of food imported into the United States.
12. Are dietary supplements food?
Yes, but they are subject to different labeling and Good Manufacturing Practice (cGMP) rules than conventional food.
13. What are Allergen rules?
Labels must clearly declare the "Major 9" allergens (e.g., milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soy, sesame).
14. What is the VQIP?
The Voluntary Qualified Importer Program provides expedited review and entry of food for participating importers.
15. What are GRAS substances?
Ingredients "Generally Recognized As Safe" that do not require pre-market food additive approval.
16. What is a Nutrition Facts Panel?
The mandatory label section displaying calories, nutrients, and daily value percentages based on serving size.
17. What are CGMPs for food?
Current Good Manufacturing Practices governing plant sanitation, hygiene, and processing controls.
18. What is Food Defense?
Procedures to protect the food supply from intentional acts of adulteration or terrorism (IA Rule).
19. Are beverage plants regulated?
Yes, facilities producing juices, bottled water, and sodas must register and follow specific safety standards.
20. What is a Section 403 violation?
The part of the FD&C Act that defines food as misbranded if its labeling is false or misleading.
21. How long are records kept?
Most FSMA records, including safety plans and monitoring logs, must be kept for at least 2 years.
22. What is an Import Alert?
A list that allows FDA to detain products without physical examination based on past violations.
23. What is Product Tracing?
The ability to track a food product one step forward and one step back in the supply chain.
24. When is a recall mandatory?
FDA can order a mandatory recall if there is a reasonable probability that food is adulterated or misbranded.
25. What is the FSVP Importer?
The U.S. owner or consignee of the food at the time of entry, responsible for supplier verification.
26. Do small farms have exemptions?
Some very small businesses have modified requirements or "qualified exemptions" under the Produce Safety Rule.
27. Can FDA inspect foreign plants?
Yes, the FDA conducts overseas inspections to ensure foreign facilities meet U.S. safety standards.
28. What are Structure/Function claims?
Claims describing the role of a nutrient intended to affect the normal structure or function in humans.
29. What is Bioengineered (BE) labeling?
Mandatory disclosure for food that contains genetic material that has been modified through in vitro rDNA techniques.
30. What is an FDA Form 483?
A report issued after an inspection listing observations that may constitute violations of FDA requirements.
31. What are Juice HACCP rules?
Specific hazard analysis requirements for juice processors to ensure 5-log reduction of pathogens.
32. How do I start the export process?
Register your facility, appoint a U.S. Agent, and ensure your labels and safety plans meet FSMA standards.