Fil-Bay Import, Inc. – FDA Warning Letter, Jun 4, 2026

Fil-Bay Import, Inc., located in Hayward, California, received a warning letter from the FDA following an inspection on June 4, 2026, as well as previous inspections in 2021 and 2022. The agency determined that the company is not in compliance with the Foreign Supplier Verification Program (FSVP) requirements established under the Federal Food, Drug, and Cosmetic Act. The primary violation is the company"s failure to develop and maintain safety verification programs for numerous imported products, including various snacks, instant coffee, noodles, and fruits in syrup. Specifically, the FDA noted that Fil-Bay did not verify or document that its thermally processed low-acid canned foods were produced in accordance with mandatory safety standards for hermetically sealed containers. While the company responded via a consultant promising to complete these programs by December 2026, the FDA found this timeline and the submitted documentation insufficient to demonstrate current compliance. The FDA has mandated that the company provide a written response within 15 working days outlining specific corrective actions and providing evidence of implemented verification programs. Failure to address these concerns may result in the FDA refusing admission of the company"s products into the United States or placing them on a detention list, which prevents distribution without physical examination.