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Premium Fresh Growers LLC failed to develop and maintain a Foreign Supplier Verification Program (FSVP) for imported fresh produce including limes, cilantro, and carrots, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. An FDA inspection conducted from October 24 to November 25, 2024, identified that the company had not implemented required risk-based verification activities to ensure imported foods met applicable U.S. food safety standards. The company did not respond to the Form FDA 483a observations issued on November 25, 2024, documenting the compliance failures.