Lempira Distribution LLC

WARNING LETTER Lempira Distribution LLC MARCS-CMS 616514 — November 03, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Mr. Carlos Vigil-Arrieta Recipient Title President Lempira Distribution LLC 8519 NW 72nd St. Miami , FL 33166-2349 United States Issuing Office: Division of Southeast Imports United States November 3, 2021 WARNING LETTER Re: CMS # 616514 Dear Mr. Vigil-Arrieta: From June 9, 2021 through July 16, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Lempira Distribution LLC, located at 8519 NW 72nd St. Miami, FL 33166. We also conducted an inspection from December 15 through December 18, 2017. 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 on July 16, 2021, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response dated July 26, 2021, and we address your response below. Your response stated that you are working on a food safety plan for each of your products and working with (b)(4) to create your FSVPs. You stated that you hoped to have a completed FSVP per product in the next few weeks. We are unable to evaluate the adequacy of your response because you did not provide further details or documentation regarding implementation of an FSVP program, and we have not received copies of your FSVPs to date. Your significant violations of the FSVP regulation are as follows: You did not develop, maintain, and implement an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop FSVPs for the food products that you import, including, but not limited to: Banana Soft Drink, imported from (b)(4) , located in (b)(4) . Sweet Bread, imported from (b)(4) , located in (b)(4) . (b)(4) Plantain Chips, imported from (b)(4) . 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. (b)(3)(A) As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law. (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. 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 these 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 your products 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 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: Ms. Ruth Dixon, Program Division Director, Division of Southeast Imports, 404 BNA Drive, Building 200 - Suite 500 Nashville, TN 37217-2565. If you have any questions regarding this letter, you may contact Ms. Coral del Mar Lopez, Compliance Officer via email at coraldelmar.lopez@fda.hhs.gov. Please reference CMS #616514 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us. Sincerely, /S/ Ruth Dixon Program Division Director Division of Southeast Imports Content current as of: 05/17/2022 Regulated Product(s) Food & Beverages