Loading…
Alma Reserve, a food and beverage importer based in Brooklyn, NY, failed to establish Foreign Supplier Verification Programs (FSVP) for imported food products including Fudge Candy, Cookies, and Rice Cakes, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1 subpart L. The company had not developed, maintained, or followed any FSVP for the foods it imported despite receiving FDA Form 483a observations during an initial inspection in December 2017 and a follow-up remote inspection in November 2020, and failed to respond to either observation. These violations represented significant non-compliance with requirements mandating importers perform risk-based activities to verify that imported human food meets applicable U.S. food safety standards.