FDA WARNING_LETTER - Daxa Foods, Inc. dba India Grocers - March 17, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Daxa Foods, Inc. dba India Grocers from March 14-17, 2022, following a previous inspection in December 2019. The inspection aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L. The FDA found the firm not in compliance with FSVP requirements, specifically noting a failure to develop, maintain, and follow an FSVP for any imported food products, including Puffed Rice, Rice Flour, and Shredded Coconut, as mandated by 21 CFR 1.502(a). The firm did not respond to the Form FDA 483a issued. This significant violation could lead to refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE), and prohibition of importation under section 301(zz). The FDA also commented that the firm might qualify as a "very small importer" under 21 CFR 1.500, which would entail modified compliance requirements. Daxa Foods, Inc. must respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation, such as a copy of their FSVP and records of its implementation.