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International General Trading Corp. failed to establish Foreign Supplier Verification Programs (FSVPs) for noodles, wafers, and hazelnut spread imported from foreign suppliers, violating section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1 subpart L. During a March-April 2021 remote inspection, FDA investigators identified these significant compliance gaps and provided Form FDA 483a observations, to which the company had not responded as of the warning letter date. This represented a repeat violation, as a prior FSVP inspection in August 2018 had also documented deficiencies without adequate corrective action.