BN Trading, Inc. – FDA Warning Letter, Jun 25, 2021

On October 1, 2021, the FDA issued a Warning Letter to BN Trading, Inc. following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from June 14-25, 2021, and a previous inspection on April 10, 2020. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate importers perform risk-based activities to verify imported food meets U.S. food safety standards.

The FDA found BN Trading, Inc. was not in compliance, specifically failing to develop, maintain, and follow an FSVP for any imported foods, including dry mallow molokhia, tahina, eggplant makdous, soup starter, and organic chestnuts roasted and peeled. This constitutes a significant violation of section 805 of the FD&C Act and 21 CFR 1.502(a).

The company's July 3, 2021, response, stating intent to comply and needing six months to develop FSVPs, was deemed inadequate due to lack of detail and supporting documentation.

The FDA warned that failure to adequately address these violations could lead to refusal of admission for imported food under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert