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Blue Stone Import USA Inc., a food importer based in New York, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation for imported food products including spicy chicken flavor ramen and wheat flour. The company did not develop, maintain, or follow any FSVP plan as required by the Federal Food, Drug, and Cosmetic Act, despite being subject to FDA inspections in May 2019, February 2021, and most recently May-June 2022. The company also failed to respond to the FDA Form 483a observations issued at the conclusion of the June 2022 inspection, which documented these significant violations.