Applicability review
We confirm which FSMA rules apply to your operation, including any exemptions or modified requirements, before writing a single document.
FSMA compliance consultant · Miami, FL
FSMA compliance for manufacturers and importers who expect FDA at the door
We prepare PCQI-led food safety plans, build Foreign Supplier Verification Programs for importers and get your traceability records ready for the FSMA 204 compliance date.
What does FSMA require of a food facility? Most FDA-registered facilities must have a written food safety plan prepared or overseen by a Preventive Controls Qualified Individual (PCQI): hazard analysis, preventive controls, monitoring, corrective actions, verification, a recall plan and records. Importers also need an FSVP, and foods on the Food Traceability List need FSMA 204 records by July 20, 2028.
Juan S. VargasSQF Food Safety Auditor · Exemplar Global
- Certified SQF auditorExemplar Global · 2024
- On-site, hands-onMiami-based · across the U.S.
- English & SpanishBilingual training
- Free 30-min gap callReply within one business day
Who it's for
Who needs FSMA and PCQI consulting
The Food Safety Modernization Act (FSMA) moved FDA from reacting to outbreaks to requiring prevention. In practice that means written plans, qualified people and records that an FDA inspector can review on the spot. We work with:
- Food manufacturers and processors registered with FDA that have a HACCP plan but no complete preventive controls food safety plan
- Importers of food ingredients, seafood, produce and packaged goods that must run an FSVP for each foreign supplier
- Warehouses and distributors that hold, repack or relabel food and need to know which FSMA rules apply to them
- Handlers of Food Traceability List foods preparing key data elements and lot codes for FSMA 204
- Sites after an FDA inspection that received observations and need a corrective plan that holds up
The problem
Why food safety plans and FSVPs fail FDA review
FDA inspectors do not grade you on format. They ask to see the plan, check that the hazard analysis matches what you make, and then ask for the monitoring, verification and supplier records that prove the controls run. The common failures are predictable.
A HACCP plan labeled as a food safety plan
Allergen, sanitation and supply-chain preventive controls are missing because the plan only covers CCPs.
No real PCQI
Nobody on staff completed PCQI training or can explain the hazard analysis, and the plan has no evidence of who prepared or oversaw it.
Supply-chain controls on paper
Hazards that a supplier controls are listed, but there is no supplier approval, no verification activity and no record of either.
FSVP without a hazard analysis
The importer holds a certificate from the supplier but never evaluated the hazards of the food or the supplier's performance.
Records that stop
Monitoring and verification logs that exist for the first month after the plan was written, then go quiet.
No reanalysis
New products, suppliers or equipment were added and the plan was never reanalyzed.
What's included
What our FSMA consulting service includes
Food safety plan (PC Human Food)
Hazard analysis and preventive controls prepared with your team and overseen by a PCQI, with monitoring, corrective action and verification procedures.
PCQI training & support
Guidance for staff taking a PCQI course and hands-on coaching so your PCQI can maintain, reanalyze and defend the plan.
FSVP for importers
Hazard analysis per food, foreign supplier evaluation, verification activities and records organized by supplier.
Food defense plan
Vulnerability assessment and mitigation strategies for facilities covered by the Intentional Adulteration rule.
FSMA 204 traceability readiness
Food Traceability List review, critical tracking events mapped, key data elements defined and a lot code system you can report from.
The regulation
FSMA rules, who they apply to and what they require
FSMA is not a single requirement. It is a set of FDA rules, and each one applies to a different part of the supply chain. Most facilities fall under more than one.
| FSMA rule | Who it applies to | Core requirement |
|---|---|---|
| Preventive Controls for Human Food (21 CFR 117) | FDA-registered facilities that manufacture, process, pack or hold human food | CGMPs plus a written food safety plan prepared or overseen by a PCQI |
| Foreign Supplier Verification Programs (21 CFR 1 Subpart L) | U.S. importers of food | Hazard analysis, supplier evaluation and verification for each imported food and supplier |
| Produce Safety Rule | Farms that grow, harvest, pack or hold produce | Standards for water, soil amendments, worker hygiene, animals and equipment |
| Intentional Adulteration | Food facilities, with exemptions for very small businesses | A written food defense plan with mitigation strategies |
| Sanitary Transportation | Shippers, loaders, carriers and receivers of food | Sanitary vehicles, temperature control and training |
| Food Traceability Rule (FSMA 204) | Anyone who manufactures, processes, packs or holds foods on the Food Traceability List | KDEs at CTEs, traceability lot codes and records to FDA within 24 hours; compliance by July 20, 2028 |
Elements of a FSMA food safety plan
| Element | What FDA expects to see |
|---|---|
| Hazard analysis | Known or reasonably foreseeable biological, chemical and physical hazards evaluated for each product and step |
| Preventive controls | Process, food allergen, sanitation and supply-chain controls, plus any other controls the hazard analysis requires |
| Supply-chain program | Supplier approval and verification when a hazard is controlled before the food reaches you |
| Recall plan | Written steps to notify consignees, the public if needed, and to handle recalled product |
| Monitoring & corrective actions | How each control is checked and what happens when it fails |
| Verification | Validation, calibration, record review and testing where appropriate |
| Records | Documentation showing the plan is implemented, reviewed and reanalyzed |
Who can be a PCQI? A Preventive Controls Qualified Individual is someone who has completed training under a standardized curriculum recognized by FDA, or is otherwise qualified through job experience to develop and apply a food safety system. The PCQI prepares or oversees the plan, its validation, record review and reanalysis. Seafood (21 CFR 123), juice (21 CFR 120) and USDA-inspected meat and poultry (9 CFR 417) follow their own HACCP rules; see HACCP consulting and our comparison of FSMA vs HACCP vs SQF.
How we work
From applicability review to an inspection-ready file
Gap analysis
We confirm which rules apply, walk the facility, and review your current HACCP plan, CGMPs, supplier files, import records and traceability practices.
You receive: applicability summary, gap report and prioritized action plan.
Plan build & training
Food safety plan, FSVP, food defense plan and traceability procedures written with your team, then PCQI coaching and bilingual training for the people who keep the records.
You receive: food safety plan, FSVP files by supplier, forms and training records.
Mock inspection & follow-up
A mock FDA-style inspection and a traceability exercise that tests whether you can produce the records requested, followed by corrective actions.
You receive: mock inspection report, corrective action log, reanalysis calendar.
Local angle
FSVP and FSMA 204 in Miami's import corridor
Miami is a gateway for food coming from Latin America and the Caribbean: fresh produce, seafood, coffee, frozen fruit, sauces and specialty ingredients move through the port, the airport and the warehouse districts of Doral and Medley. For many of these companies the U.S. importer is responsible for the FSVP, not the foreign supplier.
Many produce and seafood items handled here also appear on the Food Traceability List, so the same importers will need FSMA 204 records by July 20, 2028.
We work on both sides of that trade. For Miami importers we build FSVP files supplier by supplier. For exporters in Mexico, Guatemala, Colombia, Peru, Ecuador or Chile we help prepare the documents and controls U.S. importers ask for, in Spanish; see exportar alimentos a Estados Unidos (FSMA).
Produce suppliers often combine FSMA with a buyer-required audit such as PrimusGFS.
Results
FSMA case records
CASE 01 · SAUCE & DRESSING MANUFACTURER
18,000 sq ft · Fort Lauderdale, FL
- Standard
- FSMA Preventive Controls + HACCP
- At gap analysis
- No written food safety plan
- At certification audit
- PCQI-led plan in place
- Outcome
- FDA inspection closed, no 483
8 weeks
Illustrative engagement · real client data pending authorization
FAQ
Frequently asked questions
Do we need a PCQI on staff?
The rule requires the food safety plan to be prepared or overseen by one or more PCQIs, and it does not require that person to be an employee. In practice, having a trained PCQI on staff makes it far easier to maintain records, review them on time and reanalyze the plan when something changes. We support both models.
What is the difference between a HACCP plan and a FSMA food safety plan?
A HACCP plan controls hazards at critical control points. A FSMA food safety plan also covers food allergen, sanitation and supply-chain preventive controls, a recall plan and verification, and it must be prepared or overseen by a PCQI. A good HACCP plan is a strong starting point, not the finished plan.
Does FSVP apply to my import company?
If you are the U.S. owner or consignee of imported food at the time of entry, or the designated U.S. agent, FSVP generally applies to you, with some exemptions and modified requirements. We review your products, suppliers and entry documents to confirm who the FSVP importer is and what you must keep on file.
When do we need to comply with FSMA 204?
The Food Traceability Rule compliance date is July 20, 2028. If you manufacture, process, pack or hold a food on the Food Traceability List, you will need key data elements at critical tracking events, traceability lot codes and the ability to send records to FDA within 24 hours of a request.
How much does FSMA compliance consulting cost?
It depends on how many products and suppliers are involved, whether a HACCP plan and prerequisite programs already exist, and whether you need FSVP or traceability work too. We quote a fixed scope after a 30-minute gap call.
Free gap call
Have an audit on the calendar?
In 30 minutes we review your standard, your date and your most likely gaps, and tell you honestly whether you need us.
- +1 786 209 7451
- Mon–Fri · 8:00 AM – 5:00 PM ET
- jusevalu02@gmail.com
- 5.0 on Google
Juan S. VargasSQF Food Safety Auditor · PCQI
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