Fil-Bay Import, Inc.

WARNING LETTER Fil-Bay Import, Inc. MARCS-CMS 734615 — July 20, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Alfred Y. Kwong, CEO Recipient Title Lourdes C. Kwong, General Manager Fil-Bay Import, Inc. 2850 Breaker Cir Hayward , CA 94545-1349 United States Issuing Office: Office of Inspections and Investigations United States July 20, 2026 WARNING LETTER Re: CMS 734615 Dear Mr. Kwong and Ms. Kwong: On June 4, 2026 the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Fil-Bay Import, Inc. located at 2850 Breaker Cir, Hayward, CA 94545-1349. We also conducted inspections on February 22-24, 2021 and July 26-August 1, 2022. 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 investigators provided you with a Form FDA 483a FSVP Observations. We acknowledge receipt of your response dated June 11, 2026, submitted via email by (b)(4) , who identified themselves as your consultant and 3rd Party Qualified Individual (QI), in which your consultant stated your FSVPs would be completed within 180 days, on or about December 8, 2026. The documents included your FSVP SOP and evaluation documents for the discontinuation of the use of foreign supplier, (b)(4) as the supplier of sweet sugar palm. You also provided documents associated with the foreign suppliers (b)(4) . However, it is not clear how these documents would apply to your FSVP program, and you did not explain how they would apply to your FSVP program. 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 some of the foods you import, including each of the following foods: (b)(4) Cracklings Snacks you imported from (b)(4) located in the (b)(4) (b)(4) Chips Snacks you imported from (b)(4) located in the (b)(4) Nata De Coco in Syrup you imported from (b)(4) located in the (b)(4) Fruit Mix in Syrup you imported from (b)(4) located in the (b)(4) Red Mung Beans in Syrup you imported from (b)(4) located in the (b)(4) Coconut (b)(4) in Syrup you imported from (b)(4) located in the (b)(4) (b)(4) Banana Leaves you imported from (b)(4) located in the (b)(4) (b)(4) Banana Leaves you imported from (b)(4) located in the (b)(4) Instant Coffee you imported from (b)(4) located in the (b)(4) Instant Coffee you imported from (b)(4) located in the (b)(4) Corn Chips you imported from (b)(4) located in the (b)(4) Biscuits you imported from (b)(4) located in the (b)(4) Noodles you imported from (b)(4) located in the (b)(4) Biscuits you imported from (b)(4) located in the (b)(4) Purple Yam Jam you imported from (b)(4) located in the (b)(4) Coconut Gel in Syrup you imported from (b)(4) located in the (b)(4) Fruit Mix in Syrup you imported from (b)(4) located in (b)(4) Sugar Palm Fruit in Syrup you imported from (b)(4) located in the (b)(4) White Beans in Syrup you imported from (b)(4) located in the (b)(4) Coconut (b)(4) in Syrup you imported from (b)(4) located in the (b)(4) For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). However, you did not verify and document that the canned food products you import, including but not limited to Nata De Coco in Syrup, Fruit Mix in Syrup, Red Mung Beans in Syrup, & Coconut (b)(4) in Syrup you imported from (b)(4) located in the (b)(4) and Coconut (b)(4) in Syrup, Fruit Mix in Syrup, White Beans in Syrup, & Purple Yam Jam imported from (b)(4) located in the (b)(4) were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1). 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 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: Sandra K. Wangen Compliance Officer, Division of West Coast Imports, 934 Broadway, Suite 101, Tacoma, WA 98402; or via email to wcid@fda.hhs.gov, Attention: Sandra K. Wangen, Compliance Officer. If you have any questions regarding this letter, you may contact Sandra K. Wangen via email at sandra.wangen@fda.hhs.gov. Please reference CMS # 734615 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/ Dr. Kathleen Turner Program Division Director Division of West Coast Imports Content current as of: 09/29/2026 Regulated Product(s) Food & Beverages