FDA Warning Letter: Importer Failed to Establish FSVP After Three Inspections
On October 23, 2025, FDA issued a warning letter to MG Group USA, a specialty food importer based in Harrison, New York, for complete failure to develop, maintain, or follow a Foreign Supplier Verification Program (FSVP) as required by FSMA. What makes this case particularly significant is that FDA conducted three separate inspections between 2023 and 2025—and despite receiving FDA Form 483a observations after each inspection, the company provided no documentation showing any FSVP compliance for imported truffle products.
What Happened
MG Group USA imports specialty foods including white truffle olive oil, fresh summer truffles, and fresh black truffles from foreign suppliers in Europe. FDA conducted FSVP compliance inspections on three occasions:
February 8-21, 2023: First inspection identified FSVP violations
September 9-16, 2024: Second inspection showed violations persisted
August 14, 2025: Third inspection confirmed still no FSVP in place
At the conclusion of each inspection, FDA provided the company with Form 483a documenting FSVP observations. Despite submitting written responses, MG Group USA failed to provide any documentation demonstrating that it had developed FSVPs for any of the foods it imports.
Key Violations
The warning letter (CMS # 718152) cited violations of Section 805 of the FD&C Act (21 U.S.C. § 384a) and the implementing FSVP regulation in 21 CFR Part 1, Subpart L:
No FSVP Developed (21 CFR § 1.502(a)): The company did not develop an FSVP for any imported foods, including products from multiple foreign suppliers across different countries. This is not a paperwork deficiency—it represents complete absence of the required program.
Multiple Inspections, Same Violations: Three inspections over 2.5 years gave the company ample opportunity and notice to correct violations. The repeated non-compliance demonstrates willful disregard for FSMA requirements and significantly increases the likelihood of escalated enforcement.
High-Risk Products: Fresh truffles are perishable imported foods with potential contamination risks. Even premium products from European suppliers require FSVP verification—geographic origin does not exempt importers from compliance.
FDA's Explicit Warnings
The warning letter is notable for FDA's direct language about impending enforcement escalation:
Import Alert 99-41 (FSVP-Related DWPE): FDA explicitly referenced placing the company on Detention Without Physical Examination (DWPE), meaning all future shipments would be automatically detained at the border without FDA physically inspecting them. Once on DWPE, the importer must provide evidence of FSVP compliance before each shipment is released—causing delays, storage fees, and potential spoilage for perishable products.
Refusal of Admission (21 U.S.C. § 381(a)(3)): FDA warned it may refuse admission of foods imported by firms appearing to violate Section 805, meaning shipments cannot legally enter U.S. commerce and must be exported at the importer's expense or destroyed.
Criminal Liability (21 U.S.C. § 331(zz)): The warning letter noted that importing food without a compliant FSVP is a prohibited act under Section 301(zz) of the FD&C Act, which can result in criminal charges, including misdemeanor charges for first offenses and felony charges for subsequent violations.
Why This Matters for All Food Importers
FSVP is not optional, and company size or import volume does not create an exemption. Key takeaways from this enforcement action:
FSVP applies to all food importers: If you are the owner or consignee of food at the time of entry into the United States, you are the importer under FSVP. This includes:
Small specialty food importers
Distributors sourcing from foreign manufacturers
Retailers with private label products made abroad
E-commerce businesses drop shipping food from foreign suppliers
Brands using co-manufacturers located outside the U.S.
Your broker doesn't handle FSVP: Many importers mistakenly believe their customs broker establishes FSVP compliance. Customs brokers facilitate entry documentation—they do not and cannot perform FSVP verification activities on your behalf. The importer is legally responsible.
Form 483 requires immediate action: When FDA issues Form 483 observations, immediate corrective action is required. Ignoring 483 observations, providing incomplete responses, or failing to implement corrections escalates enforcement to warning letters and beyond.
Premium products aren't exempt: The fact that MG Group imported high-end truffle products from European suppliers is irrelevant. FSVP applies regardless of product price point, country of origin, or supplier reputation.
Documentation is mandatory: FSVP is not just a process—it requires written documentation proving compliance. You must maintain records of hazard analysis, supplier evaluations, verification activities, and corrective actions for each food and foreign supplier.
What FSVP Requires
The FSVP regulation requires importers to perform specific risk-based activities to verify that imported food meets applicable U.S. food safety standards:
Hazard Analysis: Evaluate known or reasonably foreseeable hazards for each food you import
Supplier Evaluation: Assess each foreign supplier's ability to produce safe food
Verification Activities: Conduct appropriate supplier verification (audits, sampling/testing, record reviews)
Corrective Actions: Implement corrective actions when verification reveals problems
Reassessment: Reassess your FSVP at least every 3 years or when circumstances change
Documentation: Maintain records demonstrating FSVP compliance for each food/supplier combination
FSVP became enforceable on May 30, 2017 for most importers, meaning MG Group USA has been subject to these requirements for over 8 years. The company had ample time to come into compliance.
Consequences of Non-Compliance
Beyond this warning letter, importers without compliant FSVPs face:
Automatic detention: All shipments stopped at the border until FSVP documentation is provided
Refused entry: Products cannot enter U.S. commerce and must be exported or destroyed
Public database: Import refusals are searchable in FDA's OASIS database, damaging business reputation
Lost business: Delays and detention mean lost sales, spoiled perishable goods, and dissatisfied customers
Criminal prosecution: Prohibited acts can result in imprisonment and substantial fines
Business closure: Inability to import effectively ends the business for import-dependent companies
Take Action Now
If you import food and don't have a documented FSVP:
Stop imports immediately until FSVP is established
Conduct hazard analysis for each food you import
Evaluate and approve each foreign supplier
Determine appropriate verification activities (audits, testing, or record review)
Document everything in writing
Implement before next import
Don't wait for an FDA inspection. By the time FDA shows up, you should already have a complete, documented FSVP ready for review.
Get the Full Enforcement Breakdown
Compliance Vault subscribers receive comprehensive analysis of every major FDA enforcement action, including:
✓ Complete FSVP implementation guide with step-by-step instructions for each requirement
✓ Hazard analysis worksheets for different food categories
✓ Supplier evaluation templates with criteria checklists
✓ Verification activity decision trees showing when to audit vs. test vs. review records
✓ Required documentation checklist ensuring you maintain all necessary FSVP records
✓ Response strategy if you receive an FDA warning letter or 483 observations
The full MG Group enforcement breakdown includes detailed FSVP building instructions, sample documentation templates, and a prevention checklist specifically for food importers.
Related Topics: FDA Warning Letters, FSVP, Food Safety Modernization Act, Import Compliance, Foreign Supplier Verification, Import Detention, Form 483
Legal Citations:
FD&C Act § 805, 21 U.S.C. § 384a - FSVP requirement
FD&C Act § 301(zz), 21 U.S.C. § 331(zz) - Prohibited act (importing without FSVP)
FD&C Act § 801(a)(3), 21 U.S.C. § 381(a)(3) - Refusal of admission for FSVP violations
21 CFR Part 1, Subpart L (21 CFR §§ 1.500-1.514) - FSVP implementing regulations
Import Alert 99-41 - FSVP-related Detention Without Physical Examination
FDA Warning Letter Reference: CMS # 718152, October 23, 2025
Company: MG Group USA, Harrison, NY
Issuing Office: Division of Northeast Import Operations
Products Affected: White Truffle Olive Oil, Fresh Summer Truffles, Fresh Black Truffles