Tijuana’s Produce Inc. – FDA Warning Letter, May 2, 2023

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection at Tijuana’s Produce Inc. from April 27 to May 2, 2023, following previous inspections, to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L. The inspection revealed significant violations, indicating the firm is not in compliance with FSVP requirements. Specifically, Tijuana’s Produce Inc. failed to develop, maintain, and follow an FSVP for imported foods, including fresh seedless watermelon and fresh cucumbers, as required by 21 CFR 1.502(a). Additionally, the firm was unable to explain how its third-party food safety audits for Fresh Persian Limes considered the Produce Safety Rule (21 CFR part 112), demonstrating a deficiency in their foreign supplier verification activities as per 21 CFR 1.506(e)(1)(i)(B). The FDA requires a written response within fifteen working days detailing specific corrective actions, including documentation of changes to their FSVP and records demonstrating its implementation. Failure to adequately address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, detention without physical examination, and prohibition of importation under section 301(zz).