FDA Consultant for Food and Beverage Manufacturers
Our FDA consultants and former auditors handle the requirements that keep your product legal to sell: facility registration, labeling, imports, additives, inspection readiness, and Form 483 responses.
- Food facility registration, labeling, and imports in one team
- FDA inspection preparation and Form 483 response support
- Guidance from a team that has run more than 500 audits
A 30-minute call with an FDA expert. No cost and no obligation.
- 500+
- Facilities audited by our lead consultant Dave Seddon
- 9
- Major allergens a compliant label must declare
- 15
- Days FDA window to respond to a Form 483
- 30
- Minutes of free consultation to get started
What does an FDA consultant do?
An FDA consultant helps food manufacturers, processors, importers, and distributors meet the rules the U.S. Food and Drug Administration enforces. The FDA does not pre-approve most foods the way it approves drugs. Instead, it expects your facility to be registered, your labels to be correct, your imports documented, and your operation ready for inspection at any time.
Those obligations are wide. They include getting and keeping your facility registration, building compliant labels, clearing imports through the border, meeting the rules for additives and ingredients, and having a recall plan that works. We bring that whole picture and prioritize the requirements that carry the most risk if they slip.
Our consultants have sat on the auditor side of the table. We know what an FDA investigator looks for and how to make sure your facility, records, and team are ready before one arrives.
Working on preventive controls or traceability? Those are governed by the Food Safety Modernization Act. See our dedicated FSMA compliance page for that side of the work. This page covers the broader FDA requirements around it.
FDA compliance, end to end
One team across the FDA requirements a food business has to meet. Engage us for a single area or the whole program.
Food facility registration
Initial registration, biennial renewal, and the FDA establishment identifier.
Food and beverage labeling
Nutrition Facts, ingredient lists, allergen declarations, net quantity, and claims.
Imports and prior notice
Prior notice filings, U.S. agent, and support with detentions and import alerts.
Inspections and Form 483
Inspection readiness, 483 responses, and warning letter remediation.
Recalls and reporting
Recall plans, mock recalls, and Reportable Food Registry submissions.
Additives, GRAS, and food contact
Ingredient status, GRAS determinations, and food contact notifications.
Acidified and low-acid canned foods
LACF and acidified food registration and process filings.
U.S. agent for foreign facilities
The required U.S. contact for facilities located outside the country.
Sanitation and cGMP baseline
Sanitation, hygiene, and cGMP under 21 CFR Part 117, the rule that also carries FSMA preventive controls.
The FDA requirements manufacturers ask about most
A closer look at the areas where a mistake is expensive. We confirm what applies to your product and handle each one.
Food facility registration
Any facility that manufactures, processes, packs, or holds food for the United States must register with the FDA and renew that registration on a set schedule. Foreign facilities also need a U.S. agent.
- Initial registration and FDA establishment identifier
- Biennial renewal in every even-numbered year
- Separate filings for acidified and low-acid canned foods
RENEWAL
- Every even year
October 1 to December 31.
Food and beverage labeling
Labeling is one of the most common reasons product gets pulled or detained. We review and build labels that meet FDA rules under 21 CFR Part 101 before they go to print.
- Nutrition Facts and Supplement Facts panels
- Ingredient and sub-ingredient declarations
- Allergen labeling for the nine major allergens, including sesame
- Net quantity, claims, and country of origin
MAJOR ALLERGENS
- 9
Sesame became the ninth in 2023.
Imports and prior notice
Food imported into the United States has to clear a set of FDA requirements before and at the border. We keep your shipments moving and step in when a shipment is held.
- Prior notice for every imported shipment
- U.S. agent and registration for foreign facilities
- Support with detention without physical examination and import alerts
- Foreign Supplier Verification Program obligations, a FSMA rule we cover on our FSMA compliance page
PRIOR NOTICE
- Before arrival
Timing depends on the mode of transport.
Additives, GRAS, and food contact
Before a new ingredient or packaging material reaches product, its regulatory status has to be clear. We help you establish it and document the basis.
- Food additive and color additive status
- Generally Recognized as Safe determinations
- Food contact substance notifications
FOCUS
- Premarket
Ingredient and packaging status.
Recalls and reporting
A recall is judged on how fast and how completely you act. We build the plan, rehearse it, and manage the reporting, so a problem does not become a crisis.
- Written recall plan and recall classification
- Mock recalls and traceability checks
- Reportable Food Registry submissions within 24 hours
REPORTING
- 24 hours
Reportable Food Registry window.
Registration
Food facility registration
Any facility that manufactures, processes, packs, or holds food for the United States must register with the FDA and renew that registration on a set schedule. Foreign facilities also need a U.S. agent.
- Initial registration and FDA establishment identifier
- Biennial renewal in every even-numbered year
- Separate filings for acidified and low-acid canned foods
RENEWAL
- Every even year
October 1 to December 31.
Labeling
Food and beverage labeling
Labeling is one of the most common reasons product gets pulled or detained. We review and build labels that meet FDA rules under 21 CFR Part 101 before they go to print.
- Nutrition Facts and Supplement Facts panels
- Ingredient and sub-ingredient declarations
- Allergen labeling for the nine major allergens, including sesame
- Net quantity, claims, and country of origin
MAJOR ALLERGENS
- 9
Sesame became the ninth in 2023.
Imports
Imports and prior notice
Food imported into the United States has to clear a set of FDA requirements before and at the border. We keep your shipments moving and step in when a shipment is held.
- Prior notice for every imported shipment
- U.S. agent and registration for foreign facilities
- Support with detention without physical examination and import alerts
- Foreign Supplier Verification Program obligations, a FSMA rule we cover on our FSMA compliance page
PRIOR NOTICE
- Before arrival
Timing depends on the mode of transport.
Additives and GRAS
Additives, GRAS, and food contact
Before a new ingredient or packaging material reaches product, its regulatory status has to be clear. We help you establish it and document the basis.
- Food additive and color additive status
- Generally Recognized as Safe determinations
- Food contact substance notifications
FOCUS
- Premarket
Ingredient and packaging status.
Recalls
Recalls and reporting
A recall is judged on how fast and how completely you act. We build the plan, rehearse it, and manage the reporting, so a problem does not become a crisis.
- Written recall plan and recall classification
- Mock recalls and traceability checks
- Reportable Food Registry submissions within 24 hours
REPORTING
- 24 hours
Reportable Food Registry window.
Key FDA deadlines to plan around
Missing an FDA deadline is an avoidable risk. These are the dates we track for you so nothing slips.
| REQUIREMENT | WHEN | WHO IT APPLIES To |
|---|---|---|
| Food facility registration renewal | Oct 1 to Dec 31, 2026 | All registered food facilities, every even year |
| Prior notice for imported food | Before arrival | Importers, timed to the mode of transport |
| Form 483 response | 15 business days | Any facility issued inspectional observations |
| Reportable Food Registry | 24 hours | When you identify a reportable food safety risk |
Registration renewal opens every even-numbered year between October 1 and December 31. We file it for you so your ability to sell into the United States does not lapse.
Ready for the inspection, and for what comes after
FDA compliance is tested when an investigator walks in. We prepare you for the inspection and stand with you if observations follow.
Inspection readiness
Mock inspection, records review, and staff coaching, so your team knows what to show, what to say, and where every record lives before the FDA arrives.
Form 483 response
If an investigator issues a Form 483, we help you draft a corrective action response inside the 15 business day window the FDA expects to see it.
Warning letters and imports
If findings escalate to a warning letter, an import detention, or an import alert, we build the remediation that gets you back into compliance.
How we get your facility FDA ready
Five phases used by hundreds of manufacturers. Most sites reach inspection readiness in weeks, not months.
Gap assessment
We review your facility, filings, labels, and records against the FDA rules that apply to you, then map every gap and create a prioritized action plan.
Documentation and labels
We build the SOPs, sanitation and cGMP documentation, recall plan, and compliant labels your operation requires, including allergen and label reviews before print.
Implementation and training
We put the program to work on the floor and train your team on their responsibilities, with role-based training and records maintained on paper or in the app.
Mock inspection
We run a mock FDA inspection, identify findings, and verify corrective actions so issues are addressed before a real investigator arrives.
Filings and ongoing compliance
We handle registrations, renewals, prior notice, and import filings while keeping your program aligned as rules change, including support during inspections and for any Form 483 response.
Choose the level of support you need
Assess your compliance, build the full program, or keep your filings and readiness current. Every engagement begins with a free consultation.
FDA Compliance Assessment
Start here. Find out where you stand against every FDA rule that applies to you.
- Registration and filings check
- Label and allergen review
- Inspection readiness check
- Prioritized action plan
FDA Compliance Program
Full build. A complete, inspection-ready FDA program built and implemented with your team.
- Everything in the assessment
- Registration, labeling, and recall plan
- Import and prior notice setup
- Staff training and a mock inspection
Ongoing FDA Support
Stay current. Keep your filings current and your team ready for any inspection.
- Registration and renewal management
- Label updates for new products
- Form 483 and warning letter support
- Records maintained in the app
MEET THE LEAD OF OUR FDA TEAM
"I have audited more than 500 manufacturers. I know what an FDA investigator looks for, and I build your program, so the observations do not come."
Dave Seddon, MBA, RDN, LDN, CFSO
Co-founder of FoodReady and a finalist for SQF Auditor of the Year named by the SQF Institute.
- 500+ audits
- FDA and cGMP expertise
- USDA experience
Keep your FDA records inspection-ready every day
Consulting delivers the program. The FoodReady app helps your team keep it current: SOPs, sanitation logs, supplier documents, labels, and traceability in one place, retrievable in seconds when an investigator asks. It is optional and included with enterprise and manufacturing subscriptions.
- HACCP and food safety plan -Built and kept current.
- Traceability -Records ready for a recall.
- Supplier documents -Approval records in one place.
- Searchable archive -Any record found in seconds.
Dashboard
What manufacturers say about working with us
"They know the industry, they're professional, responsive, and here to help manufacturers to the next step so if you need a HACCP plan, need to pass an audit or are just getting started they're very helpful!"
"Eurobake passed an FDA inspection within 4 weeks of implementation, passed a GMP audit within the first 3 months, and passed a GFSI audit within the first 8 months. We also passed a Costco audit. Our timeline for preparedness was driven by Eurobake’s needs and it could have been much faster if we did not have so many unique attributes."
FDA consulting FAQ
What is an FDA Consultant?
An FDA Consultant advises food manufacturers, processors, and distributors on complying with U.S. Food and Drug Administration (FDA) regulations. This includes assistance with labeling, facility registration, FSMA compliance, food recalls, and import/export documentation. Their expertise helps ensure FDA approval or avoid penalties during inspections.
Does the FDA "approve" a food or a facility?
The FDA does not pre-approve most food facilities or products the way it approves drugs. Food facilities must register with the FDA, follow the applicable rules, keep compliant labels, and pass inspection. When people say FDA approval for food, they usually mean being registered, compliant, and inspection-ready. We handle all three.
What is the difference between FDA and FSMA?
The FDA is the agency and the full body of food regulation, covering registration, labeling, additives, imports, inspections, and recalls. FSMA, the Food Safety Modernization Act, is one law within that body that added prevention-focused rules such as preventive controls and traceability. This page covers the broader FDA requirements. For the FSMA rules specifically, see our FSMA compliance page.
How often do I renew my FDA food facility registration?
Food facilities renew their FDA registration every even-numbered year, between October 1 and December 31. Foreign facilities also need a U.S. agent. We manage registration and renewals so you do not lose your ability to sell into the United States.
Can you review my food labels?
Yes. Labeling is one of the most common reasons product gets detained or pulled. We review Nutrition Facts, ingredient declarations, allergen labeling for the nine major allergens including sesame, net quantity, and claims against FDA rules under 21 CFR Part 101, and we do it before you print.
What happens if the FDA issues a Form 483 or holds my import?
A Form 483 lists inspectional observations, the conditions an investigator believes may violate FDA rules. You should respond with a corrective action plan within 15 business days. If an import is held or placed on an import alert, the same discipline applies. We help you write the response, correct the root cause, and get product moving again.
What industries require FDA approval for food safety programs?
FDA approval is essential for industries involved in food manufacturing, processing, packaging, and distribution, including specialized sectors like dietary supplements, pet foods, and beverages.
Can FDA consultants help with international regulatory compliance?
Yes, FDA consultants can align your programs with international standards such as ISO 22000 or Codex Alimentarius, ensuring compliance for businesses operating across borders.
What are the most common issues found during FDA inspections?
Common issues include inadequate sanitation practices, incomplete or missing documentation, insufficient traceability programs, and failure to comply with labeling or allergen controls. A consultant can help address these areas proactively.
How long does it take, and what does it cost?
Most facilities reach inspection readiness in weeks, depending on size and existing documentation. Cost depends on scope, from a single filing or label review to a full program. After a free consultation we provide a clear, fixed-scope quote with no surprise fees.
Get FDA compliant with confidence
Book a free consultation. We will look at your products, filings, and labels and tell you exactly what FDA compliance requires of you.