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Kari-Fresh LLC, a food and beverage importer, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) as required by federal law, despite inspections conducted in 2021 and again in June 2023. The company did not develop, maintain, and follow an FSVP to verify that imported foods met applicable U.S. food safety standards, representing a significant violation of 21 CFR Part 1 Subpart L and Section 805 of the FD&C Act. When provided an opportunity to respond to inspection findings, the company requested a six-month extension but failed to submit any documentation of corrective actions or implementation plans, leaving the FDA unable to assess the adequacy of their response.