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Keeler Family Farms, a food importer based in New Mexico, failed to establish Foreign Supplier Verification Programs (FSVP) for any of the foods it imported, including whole fresh onions from suppliers in Chihuahua, Mexico, in violation of 21 CFR Part 1 Subpart L. The inspection was triggered by a multistate Salmonella Oranienburg outbreak linked to the company's imported onions, which the firm had voluntarily recalled in October 2021. The FDA found that the company had no documented FSVP compliance procedures for any of its imported food products, representing a significant violation of Section 805 of the Federal Food, Drug, and Cosmetic Act.