FDA WARNING_LETTER - Ruth Special Food Store LLC - September 19, 2022

The FDA conducted FSVP inspections of Ruth Special Food Store LLC on August 25, 2022, through September 19, 2022, and previously from May 28, 2021, through July 27, 2021. The purpose was to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, regarding Foreign Supplier Verification Programs for imported human and/or animal food.

The most recent inspection revealed a significant violation: the company failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported foods. The company admitted to not developing FSVPs and provided supplier documents (e.g., Cleaning Validation Procedure, Certificates of Analysis, Inspection Certificates) but no record of review or explanation of their application to an FSVP. These documents alone do not constitute an FSVP.

The FDA issued a Form FDA 483a FSVP Observations on September 19, 2022, to which no response has been received. Failure to adequately address this violation may lead to further action, including refusal of admission of imported food under Section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under