Foreign Supplier Verification Program (FSVP): FDA Warning Letter to Boba Factory Inc, April 22, 2026

FDA Warning Letter — Violations FDA cited at Boba Factory Inc

WARNING LETTER Boba Factory Inc MARCS-CMS 728438 — April 22, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Reference #: 726113 Product: Food & Beverages Recipient: Recipient Name Anthony Kim Recipient Title President Boba Factory Inc 14703 Willard Rd # J Chantilly , VA 20151-1705 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States 04/22/2026 WARNING LETTER RE: CMS# 726113 Dear Mr. Anthony Kim: On February 9, 2026 through February 19, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of BOBA FACTORY INC. located at 14703 Willard Rd # J, Chantilly, VA 20151-1705. We also conducted an inspection on May 12, 2022, and December 17,2019. 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 February 19, 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: 1. Non-Dairy Creamer and Flavoring Syrup imported from (b)(4) , located in (b)(4) . 2. Dry Custard Mix 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. This letter notifies you of our concerns and provides you with 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, suc