FSVP warning letters: what FDA cites

The letters reviewed all follow the same sequence. FDA conducts an FSVP inspection of the importer: a review of its FSVP records, at the importer's location or remotely, not a visit to the foreign supplier. At the close, investigators give significant observations in writing on Form FDA 483a, FSVP Observations, and FDA's inspection fact sheet encourages a written response within 15 business days. If FDA finds the response inadequate, or cannot evaluate it, a warning letter can follow.

FDA's fact sheet lists three situations in which an FSVP inspection can occur: routine surveillance and follow-up, a compliance follow-up after a violative inspection, or products imported by the importer being associated with a recall, foodborne outbreak investigation or complaint. Investigators request records in writing, and records kept offsite must be retrievable within 24 hours.

A recurring sentence in the 2026 letters is that FDA was unable to evaluate the adequacy of the response because no supporting documentation was provided. Promising to write an FSVP was not treated as a correction; FDA asked for the documents themselves.

One 2026 letter (CMS 720186) went to a firm serving as the U.S. agent for another company. Under 21 CFR 1.500, when there is no U.S. owner or consignee at entry, the U.S. agent or representative of the foreign owner or consignee, confirmed in a signed statement of consent, is the FSVP importer and carries the importer's obligations.

• Respond in writing within fifteen (15) working days of receipt.
• Describe the specific steps taken to correct each violation.
• Include documentation, such as a copy of the FSVP and records showing it is being followed.
• If corrections will take longer, explain why and give a date.

The letters also state that the listed violations are not all-inclusive, and that the importer is responsible for full compliance with section 805 and 21 CFR part 1 subpart L.

Each letter names the same possible actions. FDA may refuse admission of the foods under section 801(a)(3) of the FD&C Act, and may place the foods on detention without physical examination when the importer imports them, through Import Alert 99-41. Importing food without an FSVP that meets section 805 is also a prohibited act under section 301(zz). Refused lines are recorded with the FSVP VIO charge code.

Import Alert 99-41 identifies the importer and may name the specific food and foreign supplier. Its Guidance section says it does not apply to all food produced by that foreign supplier, only to the specified food when imported by the listed importer.

FSVP warning letters are addressed to importers, and FDA redacts foreign supplier names, locations and many product details as (b)(4) in the posted versions. You cannot reliably search them to learn whether your supplier was involved. Warning letters issued to a foreign supplier itself, for example after an FDA inspection of its facility, are separate letters addressed to that firm, and those are what a supplier compliance check looks for.

1. 01

   List every food and supplier pair

   FDA requires an FSVP for each food from each foreign supplier. A missing pair is the 1.502(a) finding.

2. 02

   Write the hazard analysis

   One written hazard analysis per type of food, or a documented review of another entity's analysis by a qualified individual (1.504).

3. 03

   Evaluate and approve each supplier in writing

   Cover every factor in 1.505(a)(1), including all of the supplier's import alerts, warning letters and other FDA compliance actions, and sign the approval.

4. 04

   Write the verification procedures

   Choose the activities and their frequency for each pair, with an onsite audit or a written justification where a hazard could cause serious adverse health consequences (1.506).

5. 05

   Keep a change log

   Record every reevaluation, recall, positive result and corrective action as it happens (1.505(c), 1.508).

A field-by-field layout is in the FSVP supplier evaluation template.