STB Quarters, LLC – FDA Warning Letter, Mar 10, 2021

On June 8, 2021, the FDA issued a Warning Letter to STB Quarters, LLC, following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from February 1 to March 10, 2021. The inspection, initiated to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, revealed significant violations.

STB Quarters, LLC, was found to be non-compliant with FSVP requirements for all imported foods, including tahini/sesame paste from (b)(4) and sesame seeds from (b)(4). The firm failed to develop, maintain, and follow an FSVP as mandated by 21 CFR 1.502(a). Although some documents (certificates of analysis, ISO, Kosher, HACCP) were provided, they were incomplete and lacked evidence of review or application to an FSVP.

The FDA noted that the firm did not respond to the Form FDA 483a, FSVP Observations, issued at the inspection's conclusion. Failure to correct these violations may lead to refusal of admission for imported food products under Section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert #99-41. The importation of food without a compliant FSVP is prohibited under Section 301