FSVP is codified in 21 CFR Part 1, Subpart L. This guide is for educational purposes — it does not constitute legal or regulatory advice. Consult a qualified food safety professional or regulatory attorney for guidance specific to your operation.
What FSVP Is and Why It Matters
FSVP was established under the Food Safety Modernization Act (FSMA), which shifted FDA's approach from reacting to foodborne illness outbreaks to preventing them. Under FSVP, the burden of proving that imported food is safe falls on the importer — not the foreign supplier, not the customs broker, and not the shipping line.
Before FSMA, FDA had to find evidence that imported food appeared to violate US law before it could refuse entry. FSVP reversed this. Now, if FDA finds evidence that an importer does not have an adequate FSVP, it can stop shipments — even if the food itself is safe and the supplier is in full compliance.
As of early 2026, FDA has issued over 200 warning letters related to FSVP violations and placed nearly 60 importers on Import Alert 99-41, which allows detention of food without physical examination. Being placed on this alert effectively shuts down your ability to import until the deficiency is corrected. This is not a theoretical risk — it is an active enforcement priority.
Who Is the "FSVP Importer"?
This is the first question every importing company must answer, because the FSVP importer is the entity legally responsible for compliance.
Under FSVP regulations, the "importer" is the US owner or consignee of the food at the time of entry into the United States. This may or may not be the same entity as the "importer of record" for customs purposes.
If you are the US-based company that owns the food when it enters the country — meaning your name is on the commercial documents as buyer — you are almost certainly the FSVP importer. If multiple US entities could qualify as the importer, the parties should determine through written agreement who will serve as the FSVP importer and be identified as such at entry.
DUNS Number Requirement
At the time of entry, the FSVP importer must provide their name, email address, and DUNS number (Dun & Bradstreet's Data Universal Numbering System). If you do not have a DUNS number, you need to obtain one before your first import entry. The temporary "UNK" workaround that FDA allowed in earlier years was rescinded in July 2022 — a valid DUNS number is now mandatory.
Step 1: Designate a Qualified Individual
Every FSVP must be developed and overseen by a "Qualified Individual" — a person who has the education, training, or experience necessary to perform the required activities. This person does not need to be an employee of your company; you can use an external consultant or contractor. However, the FSVP importer remains legally responsible for compliance regardless of who performs the work.
Required Knowledge Areas for Frozen Produce Imports
- •Food safety hazards associated with frozen fruits and vegetables (biological, chemical, and physical hazards)
- •Supplier verification methodologies
- •FDA regulatory requirements under FSMA
- •Basic principles of HACCP and preventive controls
The most widely recognized training credential is completion of the FSPCA (Food Safety Preventive Controls Alliance) FSVP training course. While not legally required, this training is strongly recommended and demonstrates to FDA inspectors that your Qualified Individual has a baseline understanding of FSVP requirements.
Step 2: Conduct a Hazard Analysis
For each food you import, you must conduct a hazard analysis to identify known or reasonably foreseeable hazards. The analysis must address whether any of these hazards require a preventive control.
Biological Hazards
Pathogens such as Salmonella, Listeria monocytogenes, E. coli — particularly relevant for frozen produce that may be consumed without further cooking
Chemical Hazards
Pesticide residues, heavy metals, mycotoxins, allergens, processing chemicals
Physical Hazards
Foreign objects such as metal fragments, glass, stones, wood
Common Hazards for IQF Frozen Produce
- •Pathogenic bacteria on raw produce that survives freezing (freezing does not kill most pathogens)
- •Pesticide residues exceeding US EPA tolerances or FDA action levels
- •Heavy metal contamination (lead, cadmium, arsenic, mercury) from soil or water sources
- •Physical contaminants from field or processing equipment
Document the hazard analysis thoroughly. FDA inspectors will want to see your analysis, the data sources you relied on, and your conclusions about which hazards require supplier verification.
Step 3: Evaluate and Approve Foreign Suppliers
Based on your hazard analysis, you must evaluate each foreign supplier's performance and the risk posed by each food they supply.
Required Evaluation Factors
- •The hazard analysis results (what hazards does this product present?)
- •The supplier's procedures, processes, and practices related to food safety
- •Applicable FDA food safety regulations (preventive controls, produce safety standards)
- •The supplier's compliance history (including FDA warning letters, import alerts, recalls)
- •Any other relevant factors such as the supplier's food safety certifications
Specific Factors for Frozen Produce Suppliers
- •Whether the supplier holds HACCP certification and at least one GFSI-benchmarked standard (BRC, IFS, SQF, FSSC 22000)
- •Their pesticide residue management program and testing protocols
- •Their microbiological testing program (specifically for Salmonella and Listeria)
- •Their heavy metals testing program
- •Cold chain management from production through loading
- •Their export history to the United States and any previous FDA compliance issues
Based on this evaluation, you must approve the supplier before importing food from them. The approval should be documented with a clear rationale explaining why you determined the supplier adequately controls the identified hazards. This evaluation must be reassessed at least every three years — or sooner if new information becomes available.
Step 4: Determine and Conduct Verification Activities
This is the operational core of FSVP. Based on your hazard analysis and supplier evaluation, you must determine what verification activities are appropriate for each food and supplier combination.
Onsite Audits
The most comprehensive form of verification. For suppliers of products where the hazard analysis identifies a hazard requiring a preventive control, FDA generally expects annual onsite audits. Audits can be conducted by your own staff, a third-party audit firm, or can be satisfied by the supplier's existing GFSI certification audit (BRC, IFS, SQF, etc.) if you review and assess the audit report.
Sampling and Testing
Collecting samples and analyzing them for the hazards identified in your hazard analysis. For frozen produce, this typically means microbiological testing panels (TPC, coliforms, E. coli, Salmonella, Listeria), pesticide residue screening aligned with US EPA tolerances, and heavy metals panels (lead, cadmium, arsenic, mercury). Testing should be performed by accredited laboratories (ISO 17025).
Review of Supplier's Food Safety Records
Examining the supplier's own food safety documentation, such as their HACCP plan, monitoring records, corrective action reports, testing results, and complaint files. This is typically used as a supplemental verification activity rather than the sole method.
Other Appropriate Activities
Reviewing the supplier's relevant food safety certifications, reviewing inspection results from FDA or other regulatory authorities, or conducting periodic unannounced inspections.
For frozen produce — which involves biological hazards and chemical hazards — FDA expects robust verification. In practice, this means a combination of annual GFSI audit review plus periodic testing for most frozen produce suppliers.
Step 5: Take Corrective Actions When Needed
If you determine that a foreign supplier does not produce food consistent with the level of protection provided by the US food safety system, you must take prompt corrective actions.
Possible Corrective Actions
- •Requiring the supplier to implement corrective measures and verifying their effectiveness
- •Discontinuing use of the supplier until the issue is resolved
- •Taking other appropriate actions based on the circumstances
Common Triggers for Corrective Actions
- •A product test result that exceeds US limits (such as a pesticide residue detection above the EPA tolerance)
- •A foodborne illness investigation linked to the supplier's product
- •An FDA warning letter or import alert issued against the supplier
- •A failed audit finding that indicates a systemic food safety problem
- •A customer complaint indicating a food safety issue
Step 6: Maintain Records
FSVP requires detailed recordkeeping. Records must be maintained for at least two years after they were created or obtained. Records must be made available to FDA within 24 hours of a request during an inspection.
Key FSVP Records
- •Your hazard analysis for each food
- •Foreign supplier evaluation and approval documentation
- •Verification activity records (audit reports, test results, record reviews)
- •Corrective action documentation
- •Qualified Individual credentials
- •The FSVP importer's identification information (name, address, DUNS number)
Organize your records by supplier and product. For each supplier-product combination, maintain a folder (physical or digital) containing the complete FSVP documentation package. This makes FDA inspections smoother and demonstrates a systematic approach to compliance.
Step 7: Reassess Your FSVP
Your FSVP is not a one-time exercise. You must reassess it at least every three years, and whenever significant new information comes to light. Document each reassessment, including what triggered it, what you reviewed, and any changes made to the FSVP as a result.
Reassessment Triggers
- •New scientific information about hazards associated with the food
- •Changes in the supplier's operations, processes, or food safety practices
- •Supplier-related regulatory actions (warning letters, recalls, import alerts)
- •Changes in US regulatory requirements
- •Results from your own verification activities that indicate a need for revision
FSVP and Frozen Produce: Specific Considerations
Frozen fruits and vegetables present some unique FSVP considerations that importers should be aware of.
Ready-to-eat vs. not ready-to-eat classification
Many frozen fruits (strawberries, blueberries, mango) are consumed after thawing without further cooking. This means pathogenic contamination is not reduced by a consumer "kill step," making microbiological verification especially important. Frozen vegetables that are typically cooked before consumption present a lower but still significant risk.
Pesticide residue standards
US pesticide tolerances are set by the EPA and may differ from standards in the country of origin. Your hazard analysis should identify which pesticide residues are relevant to the specific crop and growing region, and your verification activities should include testing against US tolerances — not just the supplier's home country standards.
FSMA Rule 204 and traceability
As of January 2026, FSMA Rule 204 requires enhanced traceability recordkeeping for certain high-risk foods. While most IQF produce is not currently on the FDA's Food Traceability List (FTL), some fresh-cut fruits, leafy greens, and sprouts are covered. If you import any products that fall under Rule 204, additional recordkeeping requirements apply.
Modified requirements for certain situations
FSVP includes modified (less stringent) requirements for very small importers, importers of food from countries with a Food Safety Systems Recognition Arrangement (FSSRA) with the US (currently Canada, New Zealand, and Australia — notably not China), and importers of certain low-risk products.
Most frozen produce importers sourcing from China will be subject to the full FSVP requirements, not the modified versions.
What Happens During an FDA FSVP Inspection
Understanding what FDA inspectors look for helps you prepare. FDA will request access to your FSVP records for the products and suppliers they are reviewing. They will assess whether your program is complete, current, and adequately addresses the identified hazards.
Common Inspection Findings Leading to Warning Letters
- •No FSVP in place at all (surprisingly common among first-time importers)
- •Hazard analysis that fails to identify known hazards for the product category
- •No documented supplier evaluation or approval
- •Verification activities that are not appropriate to the risk (such as relying solely on COAs without any audit or independent testing)
- •Outdated records (no reassessment within three years)
- •Inability to produce records within 24 hours
The best preparation for an FDA inspection is to maintain your FSVP records in an organized, accessible system and to review them periodically — not just when an inspection is announced.
How Crestwood Global Supports FSVP Compliance
While FSVP compliance is the legal responsibility of the US importer, a cooperative supplier makes compliance significantly easier. Crestwood Global provides our US-based buyers with comprehensive documentation to support their FSVP programs.
Standard Documentation Package for Each Product
- ✓Current HACCP, BRC, and IFS certification documents for our partner production facilities
- ✓Certificate of Analysis (COA) for each production lot including full microbiological, chemical, and contaminant panels
- ✓Pesticide residue testing results from accredited third-party laboratories
- ✓Heavy metals testing results
- ✓Factory audit reports available for buyer review
- ✓Product specifications with measurable acceptance criteria
- ✓Cold chain documentation including reefer temperature logs and data logger records
We maintain these records as a standard part of our operations — not as an add-on or special request. For our US buyers, this documentation provides the foundation for a robust FSVP without requiring you to chase paperwork across time zones and language barriers.
Contact Our Team
Justin Ratti, General Manager (USA)
justin@crestwoodglobal.com
+1 (224) 534-9799
WhatsApp: +1 (802) 558-4860
Jianfang Liu, General Manager (China)
jianfangliu@hebdingyu.com
+86 133 7301 6588
Related Resources
Official FDA Resources
This guide is for educational purposes only and does not constitute legal or regulatory advice. FSVP requirements are complex and vary by product, supplier, and importer classification. Consult a qualified food safety professional or regulatory attorney for guidance specific to your operation.
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