FDA WARNING_LETTER - Great Enterprise Group Inc - April 02, 2026

The FDA issued a Warning Letter to Great Enterprise - Group - Inc. following an inspection on April 2, 2026, at their Honolulu, Hawaii facility. This inspection, alongside previous assessments dating back to 2019, focused on the company’s adherence to the Foreign Supplier Verification Program (FSVP) requirements established under the Federal Food, Drug, and Cosmetic Act. The main violations involve the company"s failure to develop and implement an FSVP for various imported foods, including hoisin sauce, canned bamboo shoots, and rice sticks. Although the company provided some documentation like invoices and certificates of analysis, they failed to conduct the required risk-based activities to verify that their foreign suppliers produce food in a manner consistent with United States safety standards. Additionally, for low-acid canned products, the importer failed to document that suppliers followed specific thermal processing regulations designed to prevent microbiological hazards. Despite a preliminary response from the company president promising future compliance, the FDA noted a lack of concrete evidence or completed program documentation. Great Enterprise - Group - Inc. is required to respond within 15 working days with a detailed plan and supporting documentation to prove they have corrected these issues. Failure to comply could lead to the FDA refusing entry of their imports or placing the products on a detention list.