FSVP Warning Letters and Import Alert 99-41 Are Rising — Here's What Produce Importers Need to Do Right Now

What is driving the enforcement wave?

Under FSMA's Foreign Supplier Verification Program regulation (21 CFR Part 1, Subpart L), every U.S. food importer must develop, maintain, and actively follow a documented FSVP for each food and each foreign supplier. For fresh produce importers specifically, FDA also expects evidence that your supplier complies with the Produce Safety Rule — a requirement many importers overlook entirely.

Since 2024, FDA has sharply accelerated FSVP inspections, often triggering them after a positive Listeria monocytogenes or other pathogen finding in an imported product. Companies importing enoki mushrooms, leafy greens, avocados, herbs, and other high-risk fresh produce have received warning letters for failing to have any documented FSVP — or for having a plan that exists on paper but was never implemented.

The most common violations FDA finds in produce importers

• No FSVP documentation at all. Many small and mid-size produce importers have never created a formal FSVP plan, assuming they were exempt or that their supplier's certifications were enough.

• Failure to address the Produce Safety Rule. For imported covered produce, your FSVP must demonstrate that the foreign supplier complies with FDA's Produce Safety Rule — not just general food safety standards.

• Incorrect "very small importer" designation. FDA has cited importers who claimed this status without documented rationale or supporting financial records, then failed to fulfill even the reduced requirements that apply.

• Missing written supplier assurances. Verbal agreements with your overseas supplier do not satisfy FDA. Written assurances and verification records must be on file, current, and supplier-specific.

• No facility registration. Several produce importers that received warning letters in 2024–2025 also had unregistered facilities, compounding their enforcement exposure significantly.

What happens when FDA places you on Import Alert 99-41?

Import Alert 99-41 — officially titled "Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with FSVP Regulation" — authorizes FDA district offices to detain your shipments at the border automatically, without inspecting them first. That means your containers of fresh tomatoes, herbs, or mushrooms sit in a bonded warehouse, deteriorating and generating storage fees, while your business loses the sale and your buyer looks elsewhere.

Getting removed from Import Alert 99-41 requires demonstrating full FSVP compliance — a process that, without expert guidance, can take months and may still be rejected by FDA if the submission is incomplete.

"Most produce importers we speak with after a warning letter had the same problem: they thought their supplier's third-party audit certificate was their FSVP. It is not. An FSVP is a U.S. importer obligation — it belongs to you, not your supplier."

How J&B Food Consulting helps produce importers resolve FSVP enforcement actions

J&B Food Consulting combines deep food safety regulatory experience with former FDA personnel who have conducted FSVP inspections themselves. We know exactly what investigators look for — because some of us were those investigators. Whether you are responding to a Form 483a, drafting a warning letter response, or seeking removal from Import Alert 99-41, our team moves quickly and precisely.

Frequently asked questions from produce importers

We already have our supplier's GFSI audit certificate. Do we still need an FSVP?

Yes. A supplier certificate can be used as one element of supplier verification activity, but the importer is still legally required to develop and maintain their own FSVP. FDA has issued warning letters specifically to companies that relied solely on supplier certificates with no importer-level documentation.

We received a Form 483a after an FSVP inspection. How long do we have to respond?

FDA expects a written response within 15 business days of receiving the Form 483a FSVP Observations. A prompt, comprehensive response demonstrating concrete corrective actions is your best path to avoiding a formal warning letter. J&B can begin your response within 48 hours of engagement.

How long does it take to get removed from Import Alert 99-41?

It depends on the completeness of your corrective action documentation and FDA's review workload. With a properly assembled compliance package, the process typically takes 2–5 months. Incomplete or poorly organized submissions can reset the clock significantly.

Is J&B Food Consulting a good fit for small produce importers, not just large companies?

Absolutely. The majority of FSVP warning letters in 2024–2025 went to small and mid-size importers, precisely because larger companies tend to have compliance infrastructure already in place. J&B works with importers of all sizes, including family-owned businesses importing a single commodity from one foreign supplier.

Contact Today: info@jnbfoodconsulting.com / 714-873-5566