FDA WARNING_LETTER - Sayar Food Market, Inc. - March 08, 2021

On July 13, 2021, the FDA issued a Warning Letter to Sayar Food Market, Inc. following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from February 16 to March 8, 2021. This inspection, along with a previous one on February 7, 2019, aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found that Sayar Food Market, Inc. was not in compliance with FSVP requirements for any imported food products, including specific items from various foreign suppliers. The company failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). The company did not respond to the Form FDA 483a, FSVP Observations, issued after both inspections.

The Warning Letter clarifies that the company's understanding of not needing to comply with FSVP regulations because products were imported from a country with an equivalent food safety system is incorrect. Even for such imports, modified FSVP requirements, including determining the foreign supplier's compliance standing, apply. The company's reported direct importer, (b)(4), located in (b)(4), does not appear to meet the definition of a foreign supplier.

Failure to address these violations may result in refusal of admission for imported food products under section 80