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Sky Global Food Inc failed to establish and maintain a Foreign Supplier Verification Program (FSVP) for imported food products including Dried Red Chili Pepper Powder, Wheat Noodle, and Dried Eggplant, in violation of section 805 of the FD&C Act and 21 CFR part 1 subpart L. The FDA inspection conducted in December 2020 (following a prior September 2018 inspection) found the company had not developed any FSVP for its imported foods and did not respond to the Form FDA 483a observations issued at the conclusion of the inspection. These significant violations meant the company was not performing the required risk-based verification activities to ensure imported foods met applicable U.S. food safety standards.