Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Piquin Y Sabores Distributors LLC, 2026-07-02
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
At a glance: On July 2, 2026, the FDA issued a warning letter to Piquin Y Sabores Distributors LLC (owner Leonardo Torres, Garland, TX) following inspections on September 25, 2024 and June 4, 2026 that found violations of the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L). The firm failed to develop and maintain an FSVP for corn chips and granola imported from specified foreign suppliers, and did not provide supporting documentation for stated corrective actions. The FDA directed a response within 15 working days detailing specific corrections and may refuse admission of imported foods or place them on detention without physical examination if violations are not adequately addressed.
Argus analysis
# FDA Warning Letter Analysis: Piquin Y Sabores Distributors LLC
Piquin Y Sabores Distributors LLC, a food importer based in Garland, Texas, received a warning letter from the FDA's Office of Inspections and Investigations on July 2, 2026, following inspections in September 2024 and June 2026. The FDA found that the company failed to establish and maintain a Foreign Supplier Verification Program (FSVP) for imported foods, specifically corn chips and granola sourced from foreign suppliers. The violations were significant enough that the agency determined the company is not in compliance with section 805 of the Federal Food, Drug, and Cosmetic Act.
The violations center on 21 CFR part 1, subpart L, which implements the FSVP requirement. This regulation obligates food importers to conduct risk-based verification activities ensuring that imported human and animal food meets applicable U.S. safety standards. The company's failure to develop, maintain, and follow an FSVP for its foreign suppliers represents a core compliance gap. The FDA cited this in 21 CFR 1.502(a), the foundational requirement for FSVP development and implementation.
The company received a 15 working-day response deadline from the warning letter's issuance. Compliance officers in the food import sector should monitor whether Piquin Y Sabores submits adequate documentation—including a written FSVP, supplier verification records, and corrective action evidence. The FDA indicated it may pursue detention without physical examination (DWPE) of imported products under Import Alert #99-41, or refuse admission of non-compliant foods entirely. Peers should note that the company's initial June 25, 2026 response lacked supporting documentation, which the FDA found insufficient for evaluation.
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 Piquin Y Sabores Distributors LLC MARCS-CMS 733360 — July 02, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Leonardo Torres Recipient Title Owner Piquin Y Sabores Distributors LLC 2002 Platinum St. Garland , TX 75042-6661 United States piquinysaboresdistributor@gmail.com Issuing Office: Office of Inspections and Investigations United States 07/02/2026 WARNING LETTER Re: CMS # 733360 Dear Mr. Leonardo Torres, On September 25, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Piquin Y Sabores Distributors LLC located at 2002 Platinum St. Garland TX 75042-6661. We also conducted an inspection on June 04, 2026. 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 June 25, 2026, in which you stated your firm will stop importing from some foreign suppliers, including (b)(4) from (b)(4) . We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions. To date, no additional FSVP documents have been received by FDA 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: Corn Chips, imported from, (b)(4) , located in (b)(4) Granola, imported from, (b)(4) , located in (b)(4) The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in c…
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 Piquin Y Sabores Distributors LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Piquin Y Sabores Distributors LLC as of 2026-07-28. Argus ingests new FDA enforcement records daily.
- What FDA violations was Piquin Y Sabores Distributors LLC cited for?
- The FDA Warning Letter to Piquin Y Sabores Distributors 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). Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Piquin Y Sabores Distributors LLC, 2026-07-02. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-piquin-y-sabores-distributors-llc-2026-07-02-warning-letter
"Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Piquin Y Sabores Distributors LLC, 2026-07-02." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-piquin-y-sabores-distributors-llc-2026-07-02-warning-letter.
Argus HQ Research. "Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Piquin Y Sabores Distributors LLC, 2026-07-02." Digital Empire Holdings LLC. Accessed July 29, 2026. https://argushq.ai/fda/warning-letter/fda-wl-piquin-y-sabores-distributors-llc-2026-07-02-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_piquin_y_sabores_distributors_llc_2026_07_02_warning_letter_2026,
title = {Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Piquin Y Sabores Distributors LLC, 2026-07-02},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-piquin-y-sabores-distributors-llc-2026-07-02-warning-letter},
note = {Accessed: July 29, 2026}
}