FDA WARNING_LETTER - Candymar Produce - November 07, 2024

On December 1, 2022, and November 7, 2024, the FDA conducted Foreign Supplier Verification Program (FSVP) inspections of Candymar Produce Inc. to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. The inspections revealed significant violations, as the firm failed to develop, maintain, and follow an FSVP for any of the foods it imports, including fresh produce that may be considered “covered produce” under 21 CFR 112.3. This non-compliance means the firm is not verifying that imported foods meet U.S. food safety standards. The FDA acknowledged the firm's November 28, 2024, response stating a consultant would be hired in January 2025 to develop an FSVP plan, but deemed it inadequate due to a lack of supporting documentation for corrective actions. The FDA requires a written response within fifteen working days detailing specific corrections, including documentation like a copy of the FSVP and records of its implementation. Failure to adequately address these violations may result in refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under section 301(zz).