FDA WARNING_LETTER - Kradjian Importing Company, Inc. - January 30, 2020

On January 30, 2020, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection at Kradjian Importing Company 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 tahina imported from three foreign suppliers and canned chick peas/garbanzo beans from one foreign supplier, as required by 21 CFR 1.502(a). For the canned chick peas, the company also failed to verify and document that the food was produced in accordance with 21 CFR part 113 (thermally processed low-acid foods), per 21 CFR 1.502(b)(1). Furthermore, for tahina, the firm did not meet requirements to conduct a hazard analysis (21 CFR 1.504), evaluate foreign supplier performance (21 CFR 1.505), or perform foreign supplier verification activities (21 CFR 1.506). The HACCP plans presented as FSVPs for tahina were also deficient. These failures indicate a lack of a robust quality system for imported foods. Kradjian Importing Company Inc. must promptly correct these violations and respond in writing within fifteen working days, providing documentation of corrective actions, such as revised FSVPs and implementation records. Failure to comply may result in refusal of admission for affected products under section 801(a)(3) of the FD&C Act, placement on Detention Without Physical Examination (DWPE) via Import Alert # 99-41, and prohibition of importation under section 301(zz).