FDA WARNING_LETTER - Kareem Mart Inc. - January 21, 2021

On May 11, 2021, the FDA issued a Warning Letter to Mohamad Jamal Eddin following a Foreign Supplier Verification Program (FSVP) inspection conducted on November 18, 2020, December 21, 2020, and January 20-21, 2021. The inspection revealed significant violations of the FSVP regulation (21 CFR part 1 subpart L) for imported products including Hummus with Tahina, Halwa with Pistachios, and Sesame Breadsticks from various foreign suppliers.

Despite claiming "very small importer" status, the importer failed to obtain required written assurances from foreign suppliers, as mandated by 21 CFR 1.512(b)(3), stating that food production meets U.S. food safety standards, including sections 402 and 403(w) of the FD&C Act. Existing assurances were deemed inadequate as they lacked product-specific information and full compliance statements.

Additionally, the importer failed to document corrective actions taken after determining a foreign supplier (Kareem Mart Inc.) produced adulterated products (positive for Salmonella), as required by 21 CFR 1.512(b)(4). While verbal action was taken to discontinue importing sesame seed products, no documentation was provided.

The FDA requires a written response within fifteen working days detailing corrective actions, including documentation of revised FSVPs