FDA WARNING_LETTER - FIDELITY MELON ,INC - January 02, 2026

The FDA issued a Warning Letter to Fidelity Melon, Inc. following inspections on December 17, 2025, and January 2, 2026. The inspection focused on the company"s adherence to the Foreign Supplier Verification Program (FSVP) requirements, as mandated by section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. The primary violation identified was Fidelity Melon"s failure to develop, maintain, and follow an adequate FSVP for the foods it imports, specifically cantaloupe and seedless watermelon. The FDA noted that while the company obtained certifications from foreign suppliers, there was no evidence these were reviewed or integrated into a comprehensive FSVP. Fidelity Melon"s subsequent response, which stated future compliance and familiarity with food hazards, was deemed insufficient due to a lack of supporting documentation for any corrective actions.

The company is required to submit a written response within fifteen working days, outlining the specific steps taken to correct the violations and achieve FSVP compliance. This response must include comprehensive supporting documentation, such as a copy of their developed FSVP and records demonstrating its implementation. Failure to adequately address these issues could result in severe consequences, including the refusal of admission for imported foods into the U.S. and their detention without physical examination.