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Facema, LLC., a food importer based in Maryland, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) as required by federal law for imported foods including tomato sauce, toffee candy, and peanuts. The company did not develop any FSVP documentation to verify that its imported foods met applicable U.S. food safety standards, representing a significant violation of 21 CFR part 1, subpart L. The violations were identified during an FDA inspection conducted from May through August 2022, and the company failed to respond to the FDA's Form FDA 483a observations issued on August 3, 2022.