FDA WARNING_LETTER - K & K Distribution, Inc. - December 03, 2020

The FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection on December 3, 2020, following an earlier inspection on February 27, 2019, to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L. The inspection revealed significant violations for saffron, chick pea candies, and frozen broad beans. Specifically, the firm failed to develop, maintain, and follow an FSVP for saffron and chick pea candies, as required by 21 CFR 1.502(a). For frozen broad beans, the firm did not meet requirements for conducting a hazard analysis (21 CFR 1.504), evaluating foreign supplier performance (21 CFR 1.505), or performing foreign supplier verification activities (21 CFR 1.506). This included a lack of documented review and assessment of the supplier's hazard analysis and performance, and insufficient assessment of third-party audits against FDA food safety regulations. These deficiencies indicate a systemic failure to implement a compliant FSVP. The FDA requires a written response within fifteen working days detailing corrective actions, including copies of developed FSVPs, implementation records, and English translations. Failure to adequately address these violations may result in refusal of admission and detention without physical examination (DWPE) for the implicated products under section 801(a)(3) of the FD&C Act, and is prohibited under section 301(zz). The firm was also reminded that previously imported products (teas, rice) would require FSVPs if re-imported.