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Talk to a SpecialistTalk to a SpecialistGW FOOD USA Inc. failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for imported foods, including Organic Soya and Seaweed & Fish Chip products from foreign suppliers, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1 subpart L. During FDA inspections conducted in May 2020 and November-December 2021, investigators found the company had not implemented the required risk-based verification activities to ensure imported foods met applicable U.S. food safety standards. The company failed to respond to the Form FDA 483a observations issued on December 2, 2021, documenting these significant compliance gaps.