Tipical Latin Food, Corp. DBA La Pradera

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 required by 21 CFR 117.139(a); 5. The written procedures for monitoring the implementation of the preventive controls, as required by 21 CFR 117.145(a); 6. The written corrective action procedures, as required by 21 CFR 117.150(a)(1); and 7. The written verification procedures, as required by 21 CFR 117.165(b). Specifically, you did not have a food safety plan with any of the required elements for any of the products manufactured by your facility, including RTE Venezuelan style cheese products (such as queso de mano, queso guayanes, and queso estilo telita). For example, you did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control (see 21 CFR § 117.130(a)(1)). Also, you did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under section 402 of the Act or misbranded under section 403(w) of the Act (see 21 CFR § 117.135(a)(1)). Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan (see 21 CFR 117.135(c)). Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR 117.140). For your RTE Venezuelan style cheese products (such as queso de mano, queso guayanes, and queso estilo telita): a. You did not identify and evaluate growth of bacterial pathogens, such as Listeria monocytogenes , as a known or reasonably foreseeable hazard to determine whether it is a hazard requiring a preventive control (see 21 CFR 117.130(b)(1)(i)). Your RTE Venezuelan style cheese products are soft and semi-soft cheese products. Your cheese products are stored in a walk-in cooler overnight before being shipped. If not properly time/temperature-controlled, the cheese products stored in your facility are likely to support the growth of bacterial pathogens (such pathogens are associated with incoming cheese curds and environmental pathogens that can be introduced in your facility). You do not monitor temperatures in your (b)(4) cooler. Your RTE soft and semi-soft cheese products are not subject to formulation control, such as lowering (b)(4) or (b)(4) to a level where pathogens would not grow, to prevent such growth. Growth of bacterial pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify growth of bacterial pathogens as a hazard requiring a preventive control (i.e., process controls). Process controls include procedures, practices, and processes to ensure the control of parameters during operations such as refrigerated finished product storage. Where appropriate, process controls must also include the parameters associated with the control of the hazard and the minimum and maximum values needed to significantly control the hazards (see 21 CFR 117.135(c)(1)). b. You did not identify and evaluate contamination with environmental pathogens, such as Listeria monocytogenes , or biological hazards due to employee handling, as known or reasonably foreseeable hazards to determine whether they are hazards requiring a preventive control, to comply with 21 CFR 117.130(c)(1)(ii). Your RTE Venezuelan style cheese products are exposed to the environment in the mixing tank, cheese press, cheese molds, and processing tables. Employees (b)(4) handle the cheese during the mixing, cutting, forming, and packaging steps. The packaged cheese does not receive any further lethal treatment or otherwise include a control measure (such as a (b)(4) lethal to the pathogen) that would significantly minimize environmental pathogens. Contamination with environmental pathogens is a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling (see 21 CFR 117.135(c)(3)). In addition, environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control (see 21 CFR 117.165(a)(3)). Your existing practices to control biological hazards due to employee handling are not adequate. For example, on April 20, 2026, and April 21, 2026, employees were observed putting on gloves when entering the RTE cheese processing area without first washing or sanitizing their hands. Employees were then observed touching soiled surfaces such as the soiled handle of a cart used to transfer the cheese from the (b)(4) to the (b)(4) that portions out the cheese with their gloved hands and then proceeding to handle RTE cheese. Employees were also observed touching their faces and soiled aprons with gloved hands before proceeding to handle the RTE cheese. In addition, employees were observed wearing multiple layers of gloves on their hands and then simply removing the outermost layer before putting on a new layer of gloves without washing or sanitizing their hands and then proceeding to handle RTE cheese. Furthermore, you did not clean and sanitize your utensils or equipment in a manner that protects against contamination. On April 21, 2026, while observing the startup of operations at your firm, the FDA investigator asked your employees if the (b)(4) screws on the cheese molding machine had been cleaned and sanitized to which they answered yes. Upon inspection of the machine, the investigator observed cheese residue on the blades of the screw that are direct food-contact surfaces and come into contact with the RTE cheese. Also, on April 20, 2026, and April 21, 2026, the FDA investigator observed that the (b)(4) molds used for the RTE cheese had white residue on the food contact surface after they were cleaned and sanitized. c. You did not identify and evaluate undeclared allergens as a known or reasonably foreseeable hazard to determine whether they are a hazard requiring a preventive control (see 21 CFR 117.130(b)(1)(ii)). Your RTE Venezuelan style cheese products contain milk. Undeclared allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in your circumstances would identify undeclared allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label (see 21 CFR 117.135(c)(2)(ii)). This is a repeat observation from the previous FDA inspections conducted on May 13, 2025, through May 19, 2025, and December 17, 2024, through December 23, 2024, where you did not have a food safety plan with any of the required elements for any of the products manufactured by your facility, including RTE Venezuelan style cheese products as described above. Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B) 1. You did not take effective measures to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 117.35(c). On April 20 and 21, 2026, while observing the processing for RTE queso de mano several live apparent flies were observed inside of the processing room landing on food contact surfaces, non-food contact surfaces, and ready to eat food products. In addition, on April 21, 2026, several small live apparent cockroaches were observed inside of the processing room where your firm processes RTE cheese. One apparent cockroach was observed crawling on the (b)(4) tray holding the clean metal mold rings used for the RTE cheese; one was observed crawling on the cheese molding machine; approximately seven were observed crawling on the box holding the plastic bags of cheese curds, and two were observed crawling on the floor in between the cheese (b)(4) machine and the cheese (b)(4) machine. The door in the (b)(4) of your (b)(4) area was observed to be left open, providing direct access to the outside of the facility on April 20, 2026, and April 21, 2026. This is a repeat observation from the previous FDA inspections conducted on December 17, 2024, through December 23, 2024. 2. Your equipment and utensils were not adequately maintained to protect against contamination, as required by 21 CFR 117.40(a)(1). On April 20 and 21, 2026, while observing processing of queso de mano, employees were observed using metal ring molds that had rough welds and overlapping seams creating crevices where food residue accumulated and making them very difficult to clean. Accumulation of black residue was observed in the crevices around those welds. This is a repeat observation from the previous FDA inspections conducted on May 13, 2025, and December 17, 2024. 3. You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically, on April 20 and 21, 2026, during the processing of RTE queso de mano cheese, the FDA Investigator observed areas of the (b)(4) room floor that were pitted and cracked, with standing water and cheese residue from processing. The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations. This letter notifies you of our concerns and provides you with an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant. Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Please send your written response electronically to: HFP-OCEConventionalFoods@fda.hhs.gov, copying Michael Dominick, Compliance Officer, at Michael.Dominick@fda.hhs.gov. If you have any questions regarding this letter, you may contact Michael Dominick, Compliance Officer, at Michael.Dominick@fda.hhs.gov. Please reference CMS #730405 on any submissions and within the subject line of any emails to us. Sincerely, /S/ Maria S. Knirk, JD MBA Director Office of Enforcement Office of Compliance and Enforcement Human Foods Program Content current as of: 10/06/2026 Regulated Product(s) Food & Beverages