On September 29, 2026 the U.S. Food and Drug Administration (FDA) published a warning letter dated July 20, 2026 to Fil-Bay Import, Inc. of Hayward, California, citing the importer for operating without a Foreign Supplier Verification Program (FSVP) for at least 20 imported foods and for failing to verify thermally processed low-acid canned foods under 21 CFR 1.502(a) and 21 CFR 1.502(b)(1). The letter, signed by the Division of West Coast Imports, follows a June 4, 2026 FSVP inspection and rejects the firm's June 11, 2026 response as inadequate.
US FSVP-regulated food and beverage importers, especially importers of Filipino and Southeast Asian snacks, syrups, coconut and fruit mixes, biscuits, noodles and instant coffee, must immediately verify and document a complete FSVP for every imported food and confirm that thermally processed low-acid canned foods were produced per 21 CFR part 113, or face FDA refusal of admission under FD&C Act section 801(a)(3), detention without physical examination under Import Alert 99-41, and the section 301(zz) prohibition on importing food without an FSVP.
- Authority : U.S. Food and Drug Administration, Division of West Coast Imports
- Entity : Fil-Bay Import, Inc., Hayward, California
- Measure and amount : warning letter, no fine at this stage
- Legal basis : FD&C Act section 805 (21 U.S.C. 384a); 21 CFR part 1, subpart L; 21 CFR 1.502(a); 21 CFR 1.502(b)(1); 21 CFR part 113
- Decision date : warning letter dated July 20, 2026, published September 29, 2026
- Compliance window : 15 working days from receipt to respond in writing
- Official source : FDA warning letter MARCS-CMS 734615 to Fil-Bay Import, Inc.
What happened
FDA investigators inspected Fil-Bay Import's FSVP records on June 4, 2026, the third such inspection after visits in February 2021 and July 2022, and issued a Form FDA 483a at its close. They found no FSVP for at least 20 imported foods, including Nata De Coco in Syrup, Fruit Mix in Syrup, Red Mung Beans in Syrup, Coconut Gel in Syrup, Sugar Palm Fruit in Syrup, White Beans in Syrup, Purple Yam Jam, Cracklings Snacks, Chips Snacks, Corn Chips, Biscuits, Noodles, Instant Coffee and Banana Leaves sourced from foreign suppliers.
Fil-Bay's consultant and third-party Qualified Individual responded on June 11, 2026, stating the FSVPs would be completed within 180 days, on or about December 8, 2026, and supplied an FSVP SOP and supplier evaluation documents. FDA found the response inadequate: the firm did not explain how those documents applied to its FSVP program.
The breach
The letter cites two significant violations. First, Fil-Bay "did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a)" for the foods it imports. Second, for thermally processed low-acid foods packaged in hermetically sealed containers, the firm did not "verify and document that the food was produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1)," covering canned products such as Nata De Coco in Syrup, Fruit Mix in Syrup, Red Mung Beans in Syrup and Purple Yam Jam.
The letter warns that FDA may refuse admission of the food under FD&C Act section 801(a)(3) (21 U.S.C. 381(a)(3)), place the firm's foods on detention without physical examination under Import Alert 99-41, and that importing food without an FSVP is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
Who else is in the same regime
The FSVP rule in 21 CFR part 1, subpart L applies to every importer of human and animal food into the United States, requiring risk-based hazard analysis and supplier verification activities for each foreign supplier. The exposed audience is not Fil-Bay but the broader US FSVP-regulated importer community: importers of Southeast Asian snacks, syrups and canned foods, importers of thermally processed low-acid canned foods under 21 CFR part 113, and any FSVP-regulated food and beverage importer that has relied on a promised timeline rather than documented records.
FDA FSVP warning letters are an active, escalating enforcement pattern, and Import Alert 99-41 detention without physical examination is the agency's primary border tool for FSVP violations. A single inadequate response, as in this letter, does not pause that exposure for the rest of the industry.
What to check now
- Confirm a complete, documented FSVP exists for every imported food under 21 CFR 1.502(a), with hazard analysis, supplier verification records and supplier approval tied to each product.
- For thermally processed low-acid canned foods, verify and document that each foreign supplier produced them per 21 CFR part 113, as required by 21 CFR 1.502(b)(1).
- Treat any FDA Form 483a as requiring a 15-working-day written response that explains how each document applies to your FSVP, not a promise of future completion.
- Review prior FSVP responses to confirm the records were actually implemented, since FDA rejected a 180-day promise here as unclear and unexplained.
- Screen your import portfolio against Import Alert 99-41 to identify foods exposed to detention without physical examination.
Continuous, per-jurisdiction monitoring surfaces an FSVP warning letter the moment FDA publishes it, before a border detention forces a response.
