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Leimax, Corp., a food importer based in Yonkers, NY, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) as required by FDA regulations for imported foods including lollipops, cola-flavored soft drinks, and hot sauce. The April 2022 inspection found that the company had not developed any FSVP for the foods it imported, despite this being a mandatory requirement under section 805 of the Federal Food, Drug, and Cosmetic Act. Additionally, the company did not respond to the FDA's Form 483a observations issued at the conclusion of the inspection on April 19, 2022. This represented a significant violation of 21 CFR part 1, subpart L, following previous FDA inspections in 2018 and 2020.