LECS USA Inc. – FDA Warning Letter, Nov 10, 2021

On November 10, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of LECS USA, Inc. to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L. The inspection revealed significant violations, primarily the firm's failure to develop, maintain, and follow an FSVP for any imported foods, including Green Tea, as mandated by 21 CFR 1.502(a). The firm claimed to be a "very small importer" but did not provide documentation to substantiate this status (21 CFR 1.500). The FDA noted that even if qualified, very small importers must still meet specific FSVP requirements, such as annual eligibility documentation and obtaining written assurances from foreign suppliers every two years (21 CFR 1.512(b)(3)(i)). The lack of a compliant FSVP means the firm is not meeting U.S. food safety standards. Failure to adequately address these violations could lead to refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE), and prohibition of importation under section 301(zz). LECS USA, Inc. must respond within fifteen working days with documentation of corrective actions, including a copy of their FSVP and records of its implementation.