FDA Warning Letter to Mesquite Gourmet LLC (2026-08-04) — Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
In short: The FDA issued a warning letter to Mesquite Gourmet LLC (MARCS-CMS 731021) on August 4, 2026, following an FSVP inspection conducted May 4-15, 2026, citing the company's failure to develop and maintain Foreign Supplier Verification Programs for imported fresh peppers (Anaheim, habanero, and jalapeno varieties) from specified foreign suppliers as required by section 805 of the FD&C Act and 21 CFR part 1, subpart L. The FDA noted that the company's May 26, 2026 response requesting a six-month extension did not adequately explain how submitted documents would apply to its FSVP program and rejected the extension request, warning that future violations could result in detention without physical examination or refusal of admission for imported foods.
Argus analysis
# FDA Warning Letter: Mesquite Gourmet LLC — FSVP Compliance Violations
Mesquite Gourmet LLC, a food importer based in San Antonio, Texas, received a Warning Letter from the FDA's Division of Southwest Imports on August 4, 2026, following inspections conducted between May and July 2026. The FDA found that the company failed to develop, maintain, and follow required Foreign Supplier Verification Programs (FSVP) for imported fresh produce—specifically Anaheim peppers, habanero peppers, and jalapeño peppers from unnamed foreign suppliers. This represents the third FDA inspection of the facility since July 2023, indicating a pattern of non-compliance.
The violations cite 21 CFR part 1, subpart L and section 805 of the Federal Food, Drug, and Cosmetic Act. These regulations require importers of human food to establish risk-based verification activities ensuring that foreign suppliers meet U.S. food safety standards. For fresh produce classified as "covered produce" under 21 CFR 112.3, importers must verify supplier compliance with the Produce Safety Rule (21 CFR part 112), which addresses growing, harvesting, packing, and holding practices. Mesquite Gourmet's submission of general FSVP policies and a six-month extension request did not adequately address the specific gaps for each supplier cited.
The company has fifteen working days from letter receipt to respond to the FDA with corrective actions and supporting documentation. Compliance officers in produce import should monitor whether Mesquite Gourmet implements supplier-specific FSVPs and whether the FDA places the company's imported produce on detention without physical examination (DWPE) under Import Alert #99-41. Failure to achieve compliance may result in FDA refusal of entry for the company's imported foods and potential enforcement action under section 301(zz) of the FD&C Act.
Severity context
Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Mesquite Gourmet LLC MARCS-CMS 731021 — August 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Mr. Oscar Andrade Recipient Title Owner and General Manager Mesquite Gourmet LLC 9901 I.H. 10 West, Suite 800 San Antonio , TX 78230-2292 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States August 04, 2026 WARNING LETTER Re: CMS 731021 Dear Mr. Oscar Andrade: On 05/04/2026-05/15/2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Mesquite Gourmet LLC located at 9901 I.H. 10 West, Suite 800, San Antonio, TX 78230-2292. We also conducted inspections on 07/19/2023-07/20/2023 and 10/15/2024-10/17/2024. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals. During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods from the foreign suppliers indicated in the attached list. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response, dated 05/26/2026, in which you requested an additional six months to implement your FSVPs for all your imported foods. Your significant violations of the FSVP regulation are as follows: You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the foods you import from the foreign suppliers indicated in the attached list, including each of the following foods: Fresh Anaheim peppers from (b)(4) Fresh habanero peppers from (b)(4) Fresh jalapeno peppers from (b)(4) In your response on 05/26/2026 you provided the following documents: Qualified Individual Certificates, a statement your firm no longer has a commercial relationship with (b)(4) , a statement your firm no longer has a commercial relationship with (b)(4) , FSVP Policies SOP, Company Overview, FSVP for (b)(4) , FSVP for (b)(4) and Formal Request for Ext…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Mesquite Gourmet LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Mesquite Gourmet LLC as of 2026-09-01. Argus ingests new FDA enforcement records daily.
- What FDA violations was Mesquite Gourmet LLC cited for?
- The FDA Warning Letter to Mesquite Gourmet LLC (issuing office: Office of Inspections and Investigations) cites: Foreign Supplier Verification Program (FSVP). Classification: Warning Letter.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Warning Letter to Mesquite Gourmet LLC (2026-08-04) — Foreign Supplier Verification Program (FSVP). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-mesquite-gourmet-llc-2026-08-04-warning-letter
"FDA Warning Letter to Mesquite Gourmet LLC (2026-08-04) — Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-mesquite-gourmet-llc-2026-08-04-warning-letter.
Argus HQ Research. "FDA Warning Letter to Mesquite Gourmet LLC (2026-08-04) — Foreign Supplier Verification Program (FSVP)." Digital Empire Holdings LLC. Accessed September 2, 2026. https://argushq.ai/fda/warning-letter/fda-wl-mesquite-gourmet-llc-2026-08-04-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_mesquite_gourmet_llc_2026_08_04_warning_letter_2026,
title = {FDA Warning Letter to Mesquite Gourmet LLC (2026-08-04) — Foreign Supplier Verification Program (FSVP)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-mesquite-gourmet-llc-2026-08-04-warning-letter},
note = {Accessed: September 2, 2026}
}