Vargas Produce LLC

WARNING LETTER Vargas Produce LLC MARCS-CMS 734510 — July 27, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Mr. Gustavo Vargas Recipient Title Owner Vargas Produce LLC 4324 W Military Hwy McAllen , TX 78503-8830 United States vargasproduce@outlook.com Issuing Office: Office of Inspections and Investigations United States July 27, 2026 WARNING LETTER Re: CMS # 734510 Dear Mr. Vargas: On June 17-18, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Vargas Produce LLC located at 4324 W Military Hwy, McAllen, TX 78503- 8830. We also conducted an inspection on February 25, 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-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 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 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 18, 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 any of the foods you import from the foreign suppliers indicated in the attached list, including each of the following foods: Cookies (b)(4) imported from (b)(4) located in (b)(4) . (b)(4) Soft Drink imported from (b)(4) , located in (b)(4) . Spicy Potato Chips imported from (b)(4) . (b)(3)(A) This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. You can find DWPE information relating to FSVP in Import Alert # 99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)). You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct any violations. You should include in your response documentation and information that would assist us in evaluating your corrections (e.g., documentation of changes you made, such as a copy of your FSVP, records to demonstrate implementation of your FSVP), and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and state when you will correct any remaining violations. Please send your reply to Food and Drug Administration, Attention: Lisa Puttonen, Compliance Officer, 1201 Main Street, Suite 7200, Dallas, TX 75202, Division of Southwest Imports. If you have any questions regarding this letter, or wish to send your response electronically, you may contact Lisa Puttonen via email at Lisa.puttonen@fda.hhs.gov. Please reference CMS # 734510 on any documents or records you provide to us and on the subject line of any email correspondence you send to us. Sincerely, /S/ Todd W. Cato Program Division Director 1201 Main Street Suite 7200 Dallas, TX 75202 Content current as of: 08/25/2026 Regulated Product(s) Food & Beverages