FDA Warning Letter to San Jorge Produce LLC (2026-07-16) — Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
Key takeaway: The FDA issued a warning letter (CMS #734097) to San Jorge Produce LLC on July 16, 2026, citing significant violations of the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) identified during inspections conducted June 1-10, 2026, and February 27–March 3, 2025. The agency found that San Jorge Produce failed to develop, maintain, and follow an FSVP for multiple fresh produce items (banana, jackfruit, jicama, lime, and plantain) imported from unnamed foreign suppliers, and did not respond to the Form FDA 483a issued on June 10, 2026. The company has 15 working days to submit corrective actions; failure to comply may result in detention of imported foods and refusal of admission under section 801(a)(3) of the FD&C Act.
Argus analysis
# FDA Warning Letter Analysis: San Jorge Produce LLC
San Jorge Produce LLC, an importer based in McAllen, Texas, received a warning letter from the FDA's Human Foods Program on July 16, 2026, following inspections conducted in February 2025 and June 2026. The FDA found that the company failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for multiple fresh produce imports, including bananas, limes, plantains, jackfruit, and jicama sourced from unnamed foreign suppliers. The violations centered on the company's inability to demonstrate that imported covered produce met U.S. food safety standards equivalent to domestic requirements.
The citations reference 21 CFR Part 1, Subpart L (the FSVP regulation implementing Section 805 of the FD&C Act) and 21 CFR Part 112 (Produce Safety Standards). These regulations require importers to conduct risk-based verification activities confirming that foreign suppliers follow produce safety protocols matching U.S. standards for growing, harvesting, packing, and holding. The absence of documented FSVP protocols constitutes a significant compliance gap, as importers bear responsibility for ensuring supplier conformity before products enter U.S. commerce.
San Jorge Produce had 15 working days from the letter date to submit a written response addressing corrective actions, including copies of newly developed FSVPs and implementation documentation. Compliance officers in produce import should anticipate that FDA may place future shipments from the identified suppliers on detention without physical examination (DWPE) under Import Alert #99-41, effectively blocking entry until compliance is demonstrated. The company's failure to respond to the initial FDA 483 observation form suggests heightened enforcement risk should adequate corrections not materialize.
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 San Jorge Produce LLC MARCS-CMS 734097 — July 16, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: San Jorge Produce LLC 6001 S International Pkwy Ste 30 McAllen , TX 78503-9049 United States Issuing Office: Human Foods Program United States July 16, 2026 WARNING LETTER Re: CMS # 734097 Dear Mr. Gomez: On June 1, 2026, through June 10, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of San Jorge Produce LLC located at 6001 S International Pkwy Ste 30 McAllen, TX 778503-9049. We also conducted an inspection on February 27, 2025, through March 3, 2025. 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-supplierverification-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 have not received your response to the Form FDA 483a issued on June 10, 2026. 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: Banana, Jackfruit, and Jicama imported from (b)(4) , located in (b)(4) . Lime imported from (b)(4) , located in (b)(4) . Lime imported from (b)(4) located in (b)(4) . Plantain, imported from (b)(4) located in (b)(4) . Banana, Plantain imported from (b)(4) located in (b)(4) Lime imported from (b)(4) located in (b)(4) . You import fresh produce that may be considered “covered produce” as defined in 21 CFR 112.3. If after review of the fresh produce that you import you determine that you are an importer of covered produce, you must have an FSVP that demonstrates that your supplier is producing the food in compliance with processes and procedures…
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 San Jorge Produce LLC had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for San Jorge Produce LLC as of 2026-07-28. Argus ingests new FDA enforcement records daily.
- What FDA violations was San Jorge Produce LLC cited for?
- The FDA Warning Letter to San Jorge Produce LLC (issuing office: Human Foods Program) 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 San Jorge Produce LLC (2026-07-16) — Foreign Supplier Verification Program (FSVP). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-san-jorge-produce-llc-2026-07-16-warning-letter
"FDA Warning Letter to San Jorge Produce LLC (2026-07-16) — Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-san-jorge-produce-llc-2026-07-16-warning-letter.
Argus HQ Research. "FDA Warning Letter to San Jorge Produce LLC (2026-07-16) — Foreign Supplier Verification Program (FSVP)." Digital Empire Holdings LLC. Accessed July 29, 2026. https://argushq.ai/fda/warning-letter/fda-wl-san-jorge-produce-llc-2026-07-16-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_san_jorge_produce_llc_2026_07_16_warning_letter_2026,
title = {FDA Warning Letter to San Jorge Produce LLC (2026-07-16) — 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-san-jorge-produce-llc-2026-07-16-warning-letter},
note = {Accessed: July 29, 2026}
}