FDA Warning Letter to Tipical Latin Food, Corp. DBA La Pradera (2026-08-28) — CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
Letter issued · posted to fda.gov .
Subject as published: CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
TL;DR
Key takeaway: FDA issued a Warning Letter on August 28, 2026, to Tipical Latin Food, Corp. DBA La Pradera (Doral, FL) following an April 20-27, 2026 inspection of its ready-to-eat Venezuelan cheese and cachapa manufacturing facility, citing violations of Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls regulations (21 CFR Part 117). The FDA determined the RTE cheese products are adulterated due to preparation, packing, or holding under insanitary conditions and identified critical deficiencies including absence of a food safety plan, failure to conduct hazard analysis for bacterial pathogens like *Listeria monocytogenes*, lack of preventive controls, and inadequate temperature monitoring in storage coolers.
Argus analysis
# FDA Warning Letter Analysis: Tipical Latin Food, Corp. DBA La Pradera
**Company and Findings**
The FDA inspected Tipical Latin Food, Corp. DBA La Pradera, a food manufacturer in Doral, Florida, from April 20–27, 2026. The facility produces ready-to-eat Venezuelan cheese products (queso de mano, queso guayanes, queso estilo telita) and cachapa. The Human Foods Program determined that the company's ready-to-eat cheese products were adulterated due to preparation, packing, and holding under insanitary conditions that may have resulted in contamination or rendered products injurious to health. The inspection identified serious violations of current Good Manufacturing Practice and preventive controls regulations.
**Regulatory Citations and Meaning**
The warning letter cites 21 CFR Part 117 (CGMP & PC rule), specifically violations across Subparts C through G. Core deficiencies include: failure to prepare a food safety plan (21 CFR 117.126); failure to conduct hazard analysis (21 CFR 117.130); failure to identify and implement preventive controls for bacterial pathogens like *Listeria monocytogenes* (21 CFR 117.135); and inadequate sanitation controls and employee handling procedures (21 CFR 117.135(c)(3)). Additionally, the company failed to establish environmental monitoring, corrective action procedures, and verification processes. These citations reflect foundational gaps in documented food safety systems required for facilities manufacturing ready-to-eat foods.
**Response Timeline and Industry Monitoring**
The FDA issued this letter August 28, 2026, noting the company had not responded to the initial Form FDA 483 issued at inspection conclusion. Compliance officers should monitor whether the company submits a timely response addressing each violation. Industry peers should watch for corrective action effectiveness, particularly whether the facility establishes documented hazard analyses, implements validated temperature controls for soft cheese storage, revises employee hygiene protocols, and establishes environmental monitoring programs before potential enforcement actions.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
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 Tipical Latin Food, Corp. DBA La Pradera MARCS-CMS 730405 — August 28, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Food & Beverages Recipient: Recipient Name Ms. Sol A. Zambrano Recipient Title President Tipical Latin Food, Corp. DBA La Pradera 1375 NW 97th Ave Ste 10 Doral , FL 33172-2855 United States (b)(6), (b)(7)(C) Issuing Office: Human Foods Program United States August 28, 2026 WARNING LETTER Re: CMS # 730405 Ms. Zambrano: The United States Food and Drug Administration (FDA) inspected your manufacturing facility, located at 1375 NW 97th Ave Ste 10, Doral, FL from April 20 through April 27, 2026. Your firm manufactures ready-to-eat (RTE) Venezuelan style cheese products (queso de mano, queso guayanes, and queso estilo telita) and cachapa (corn pancake). During the inspection, the FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA's inspectional findings, we have determined that your RTE cheese products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and FDA's regulations through links on FDA's website at www.fda.gov. At the conclusion of the inspection, the FDA investigator issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the objectionable conditions found at your facility. To date, we have not received a response to the issued FDA-483. Based on our review of the inspectional findings, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C) 1. You did not prepare, or have prepared, and implemented a food safety plan, as required by 21 CFR 117.126(a)(1). The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs), as required by 21 CFR 117.126(a)(2). Your food safety plan must also include the following: 1. The written hazard analysis, as required by 21 CFR 117.130(a)(2); 2. The written preventive controls, as required by 21 CFR 117.135(b); 3. The written supply-chain program, as required by Subpart G; 4. The written recall plan, as require…
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 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 Tipical Latin Food, Corp. DBA La Pradera had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Tipical Latin Food, Corp. DBA La Pradera as of 2026-10-06. Argus ingests new FDA enforcement records daily.
- What FDA violations was Tipical Latin Food, Corp. DBA La Pradera cited for?
- The FDA Warning Letter to Tipical Latin Food, Corp. DBA La Pradera (issuing office: Human Foods Program) cites: CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Tipical Latin Food, Corp. DBA La Pradera?
- FDA issued the letter (MARCS-CMS 730405) on 2026-08-28 and posted it publicly on fda.gov on 2026-10-06.
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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 Tipical Latin Food, Corp. DBA La Pradera (2026-08-28) — CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-tipical-latin-food-corp-dba-la-pradera-2026-08-28-cgmp
"FDA Warning Letter to Tipical Latin Food, Corp. DBA La Pradera (2026-08-28) — CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-tipical-latin-food-corp-dba-la-pradera-2026-08-28-cgmp.
Argus HQ Research. "FDA Warning Letter to Tipical Latin Food, Corp. DBA La Pradera (2026-08-28) — CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions." Digital Empire Holdings LLC. Accessed October 7, 2026. https://argushq.ai/fda/warning-letter/fda-wl-tipical-latin-food-corp-dba-la-pradera-2026-08-28-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_tipical_latin_food_corp_dba_la_pradera_2026_08_28_cgmp_2026,
title = {FDA Warning Letter to Tipical Latin Food, Corp. DBA La Pradera (2026-08-28) — CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-tipical-latin-food-corp-dba-la-pradera-2026-08-28-cgmp},
note = {Accessed: October 7, 2026}
}