FDA’s Latest FSVP Warning Letters Send a Clear Message

The FDA continues to aggressively enforce the Foreign Supplier Verification Program (FSVP), and its most recent Warning Letters reveal a common theme: importers are being cited not simply for lacking paperwork, but for failing to demonstrate meaningful oversight of their foreign suppliers.

Recent Warning Letters issued to Datil Fresh Produce LLC, Moda Food LLC, and Distribuidora Jazmin LLC demonstrate that FDA’s expectations are straightforward but demanding: every importer must have a product-specific FSVP, conduct appropriate supplier verification activities, maintain supporting records, and be prepared to produce those records during an inspection.

Lesson #1: FDA Is Still Finding Importers With No FSVP At All

The most common FSVP violation remains the complete absence of an FSVP.

In September 2026, FDA issued a Warning Letter to Datil Fresh Produce LLC after inspectors found that the company had not developed an FSVP for imported scallions, cabbage, and cucumbers. FDA specifically cited the company’s failure to develop any FSVP as required by 21 C.F.R. § 1.502(a).

The case is particularly noteworthy because the products involved were fresh produce. FDA reminded the company that covered produce importers must demonstrate that foreign suppliers are producing food in compliance with standards that provide at least the same level of public health protection as the Produce Safety Rule in 21 C.F.R. Part 112.

Similarly, FDA cited Distribuidora Jazmin LLC for failing to develop an FSVP for imported corn chips. FDA noted that although the company responded to the inspection by stating it would stop importing the product, it failed to provide documentation demonstrating corrective actions.

Takeaway: Simply discontinuing a product or supplier relationship does not resolve an FSVP violation. FDA expects documented corrective actions and supporting evidence.

Lesson #2: FDA Is Challenging Improper Reliance on Exemptions

One of the more interesting findings came from Moda Food LLC.

During FDA’s March 2026 inspection, the company reportedly argued that certain imported products were samples for food shows or research and development activities. FDA rejected the explanation because the company was unable to demonstrate that the products qualified for the research and evaluation exemption under 21 C.F.R. § 1.501(c).

FDA emphasized that to qualify for this exemption, imported food must:

• Not be intended for retail sale;
• Be appropriately labeled for research or evaluation use;
• Be imported in a quantity consistent with research purposes;
• Be accompanied by the required declaration at entry.

FDA specifically noted that some imported products did not appear to be imported in quantities consistent with research, analysis, or quality assurance purposes.

Takeaway: Importers should not assume that trade show samples, test products, or R&D imports are automatically exempt from FSVP requirements. FDA expects documentation demonstrating that every element of the exemption is satisfied.

Lesson #3: Having an FSVP Is Not Enough

Perhaps the most important enforcement trend emerging from recent Warning Letters is FDA’s focus on implementation.

In the Moda Food LLC Warning Letter, FDA acknowledged that FSVP documents existed for several products, including imported phyllo dough, baklava, and tahini halva. However, FDA found that the company failed to properly determine and document:

• Appropriate supplier verification activities;
• The frequency of those verification activities;
• Evidence that supplier verification activities were actually performed.

In other words, the company had FSVP documents, but FDA concluded that key regulatory requirements remained unmet.

Takeaway: An FSVP is not a template. FDA expects importers to make and document risk-based decisions regarding supplier oversight.

Lesson #4: Certificates Alone Do Not Constitute Supplier Verification

Another recurring issue involved overreliance on supplier certifications.

According to FDA, Moda Food LLC stated that supplier verification consisted largely of documentation review and supplier approval procedures, including reliance on various food safety certifications.

However, FDA found that the company could not produce the records it allegedly reviewed, including certificates, audit reports, or documentation showing its assessment of those records.

The Agency also emphasized that when importers rely on record review as a supplier verification activity, they must maintain documentation showing:

• What records were reviewed;
• When the review occurred;
• The conclusions reached;
• Any corrective actions taken;
• The identity of the qualified individual performing the review.

This reflects FDA’s longstanding position that a certificate in a file cabinet is not evidence of supplier verification.

Takeaway: FDA wants proof that records were reviewed and evaluated, not merely collected.

Lesson #5: Failure to Respond Can Make Matters Worse

A striking commonality among these Warning Letters is the absence of meaningful responses to FDA inspection findings.

In the case of Datil Fresh Produce LLC, FDA stated that it had not received a response to the Form FDA 483a issued at the conclusion of the inspection.

For Moda Food LLC, FDA similarly noted that it had not received a response to the Form FDA 483a issued during the inspection.

For Distribuidora Jazmin LLC, FDA acknowledged receiving a response but found it inadequate because no supporting documentation was provided.

These examples reinforce an important reality: when FDA identifies FSVP deficiencies, the quality of the company’s response often influences the trajectory of the enforcement action.

Takeaway: FDA expects corrective action plans supported by actual records, revised procedures, training documentation, supplier evaluations, and implementation evidence.

What Importers Should Do Now

The latest Warning Letters suggest that FDA inspectors are focusing on five fundamental questions:

• Do you have a written FSVP for every imported food?
• Have you properly evaluated each foreign supplier?
• Have you selected and documented appropriate verification activities?
• Can you demonstrate that those verification activities were actually performed?
• Can you immediately produce records supporting each compliance decision?

If the answer to any of these questions is “no,” an importer may be vulnerable during an FDA inspection.

Bottom Line

The FDA’s recent FSVP Warning Letters reveal that enforcement is moving beyond basic paperwork reviews. FDA increasingly expects importers to demonstrate active supply chain oversight supported by contemporaneous records and risk-based decision making.

For many importers, the compliance gap is no longer the absence of an FSVP manual. The gap is the inability to show that the FSVP is being implemented.

And as these Warning Letters demonstrate, FDA is prepared to escalate to Warning Letters, Import Alert 99-41 placement, and detention without physical examination when importers cannot make that showing.

Garg Law Insight: If your FSVP binder looks excellent but contains little evidence of actual supplier verification activities, FDA may view your program as incomplete. The most defensible FSVPs are those that not only describe what should happen, but also document what did happen, when it happened, who performed it, and why it was appropriate for the product and supplier involved.

For questions on FSVP program development and compliance, or for other questions on strategic FDA regulatory compliance and enforcement, please contact info@garg-law.com.