Warning Letter Record: Vivot LLC (June 8, 2026) — Foreign Supplier Verification Program (FSVP)

FDA Warning Letter — Violations FDA cited at Vivot LLC

WARNING LETTER Vivot LLC MARCS-CMS 731520 — June 08, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Brandon Sangkheang Ung Recipient Title Chief Executive Officer Vivot LLC 115 E Commonwealth Ave Unit A Fullerton , CA 92832-1998 United States vivotcafe@gmail.com Issuing Office: Office of Inspections and Investigations United States June 8, 2026 WARNING LETTER Re: CMS # 731520 Dear Mr. Ung: On May 4, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Vivot LLC, located at 115 E Commonwealth Ave Unit A, Fullerton, CA 92832-1998. 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 United States 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 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 May 4, 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, including each of the following foods: (b)(4) Green Tea Powder Matcha imported from (b)(4) , located in (b)(4) . Matcha Powder imported from (b)(4) , located in (b)(4) . Green Tea imported from (b)(4) , located in (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)(4), (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), (b)(4) 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 shoul