Full Fresh Produce LLC — FDA Warning Letter, 2026-04-10: Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
At a glance: The FDA issued a warning letter to Full Fresh Produce LLC (CMS #726913) on April 10, 2026, following a Foreign Supplier Verification Program (FSVP) inspection conducted March 9-11, 2026, finding the company failed to develop, maintain, and follow required FSVPs for imported fresh mangoes, avocados, and blueberries in violation of 21 CFR part 1, subpart L and section 805 of the FD&C Act. The FDA rejected the company's March 12, 2026 response stating it lacked sufficient detail and documentation of corrective actions, and requested a written response within 15 working days addressing specific violations and demonstrating compliance, with notice that failure to do so may result in detention without physical examination of imported products and refusal of admission.
Argus analysis
# FDA Warning Letter Analysis: Full Fresh Produce LLC
**Company and Findings**
Full Fresh Produce LLC, a Miami-based importer, received a Warning Letter from FDA's Office of Inspections and Investigations on April 10, 2026, following a Foreign Supplier Verification Program (FSVP) inspection conducted March 9–11, 2026. The inspection was the fourth in the firm's record since 2021. FDA found that the company failed to develop, maintain, or follow required FSVPs for imported fresh produce, including mangoes, avocados, and blueberries. The company provided an inadequate response acknowledging only that staff would pursue FSVP training, without submitting the required verification documentation or corrective action timelines.
**Regulatory Citations**
The violations cite 21 CFR Part 1, Subpart L (the FSVP regulation implementing Section 805 of the Federal Food, Drug, and Cosmetic Act). These requirements mandate that importers of covered produce establish risk-based verification activities demonstrating that foreign suppliers comply with produce safety standards under 21 CFR Part 112. FSVP compliance requires documented supplier assessment, periodic verification, and corrective action procedures. The absence of any FSVP constitutes a direct violation of foundational import safety obligations.
**Next Steps and Monitoring**
Full Fresh Produce LLC has 15 working days to submit a written response detailing specific corrective actions, copies of developed FSVPs, implementation records, and completion timelines. Peer compliance officers should anticipate FDA may issue detention without physical examination (DWPE) orders under Import Alert #99-41 for the company's produce shipments. Repeated inspection failures since 2021 suggest escalating enforcement risk. Non-compliance could trigger import refusal under Section 801(a)(3) of the FD&C Act. Industry observers should track whether FDA pursues administrative or enforcement action if the company's response remains inadequate.
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 Full Fresh Produce LLC MARCS-CMS 726913 — April 10, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Mr. Abel Fiallo Recipient Title General Manager Full Fresh Produce LLC 17651 SW 187th Ave Miami , FL 33187 United States Issuing Office: Office of Inspections and Investigations United States April 10, 2026 WARNING LETTER Re: CMS # 726913 Dear Mr. Abel Fiallo: On March 9, through March 11, 2026, the U.S. Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Full Fresh Produce LLC, locate at 17651 SW 187th Ave. Miami, FL 33187. We also conducted inspections on June 7, 2021; September 21, 2022; and March 11, 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 food products you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the FSVP inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response dated March 12, 2026, and we address your response below. Your response stated that you will be taking the FSVP training course to become a qualified individual to develop and implement the FSVP’s for your imported foods. We are unable to evaluate the adequacy of your response because you did not provide further details or documentation demonstrating your corrective actions for all the imported foods that your firm identified as not having an FSVP in place. To date, no additional FSVP documents nor a timeframe of completion have been received by FDA. Your significant violations of the FSVP regulation are as follows: 1. 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 any foods that you import, including: Fresh Mangoes, imported from (b)(4) , located in (b)(4) Fresh Avocados, imported from (b)(4) , located in (b)(4) Fresh Blueberries, imported from (b)(4) , located in (b)(4) You import fresh p…
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
- When did FDA issue the warning letter to Full Fresh Produce LLC?
- FDA issued the letter (MARCS-CMS 726913) on 2026-04-10 and posted it publicly on fda.gov on 2026-07-14.
- Is the FDA warning letter to Full Fresh Produce LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/full-fresh-produce-llc-726913-04102026.
- What does a "low" severity rating mean for this letter?
- Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
- 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.
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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). Full Fresh Produce LLC — FDA Warning Letter, 2026-04-10: Foreign Supplier Verification Program (FSVP). Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-full-fresh-produce-llc-2026-04-10-warning-letter
"Full Fresh Produce LLC — FDA Warning Letter, 2026-04-10: Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-full-fresh-produce-llc-2026-04-10-warning-letter.
Argus HQ Research. "Full Fresh Produce LLC — FDA Warning Letter, 2026-04-10: Foreign Supplier Verification Program (FSVP)." Digital Empire LLC. Accessed July 16, 2026. https://argushq.ai/fda/warning-letter/fda-wl-full-fresh-produce-llc-2026-04-10-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_full_fresh_produce_llc_2026_04_10_warning_letter_2026,
title = {Full Fresh Produce LLC — FDA Warning Letter, 2026-04-10: Foreign Supplier Verification Program (FSVP)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-full-fresh-produce-llc-2026-04-10-warning-letter},
note = {Accessed: July 16, 2026}
}