Importaciones La Bufa LLC

WARNING LETTER Importaciones La Bufa LLC MARCS-CMS 736681 — August 17, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Mr. Ivan Alfonso Serrano Recipient Title Owner Importaciones La Bufa LLC 2303 Dorado Drive Mission , TX 78573 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States August 17, 2026 WARNING LETTER Re: CMS 736681 Dear Mr. Ivan Alfonso Serrano: On 07/15/2026-07/23/2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Importaciones La Bufa LLC located at 2303 Dorado Drive, Mission, TX 78573. This inspection was 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 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 acknowledge receipt of your response, dated 08/12/2026, in which you stated you have developed and implemented a written FSVP program that establishes the procedures your company will follow. You also provided your FSVP Processes and Procedures document. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions. To date, no additional FSVP documents have been received by FDA. 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. The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L. 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 from the identified foreign suppliers 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: Zumera Ajani, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, or wish to send your response electronically, you may contact Zumera Ajani via email at Zumera.Ajani@fda.hhs.gov. Please reference CMS # 736681 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 Division of Southwest Imports Content current as of: 10/06/2026 Regulated Product(s) Food & Beverages