FDA WARNING_LETTER - Madras Groceries - January 05, 2022

On December 17, 2021, and January 3-5, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Madras Groceries in Sunnyvale, CA, following a previous inspection on March 26, 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 that Madras Groceries failed to develop, maintain, and follow an FSVP for any imported foods, a significant violation of 21 CFR 1.502(a) and section 805 of the FD&C Act. The firm did not respond to the Form FDA 483a issued on January 5, 2022. The letter notes that the firm might qualify as a "very small importer" under 21 CFR 1.500, which would entail modified requirements, including documenting this status and obtaining written assurances from foreign suppliers every two years. Failure to address these violations 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 under section 301(zz). Madras Groceries must respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation, or explain any delays.