FDA WARNING_LETTER - Minuti Coffee LLC - May 20, 2022

On August 23, 2022, the FDA issued a Warning Letter to Minuti Coffee Llc, following a Foreign Supplier Verification Program (FSVP) inspection conducted from May 12-20, 2022, with an initial inspection on October 29, 2019. The inspection found the firm non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. safety standards.

The significant violation identified was the failure to develop, maintain, and follow an FSVP for imported foods, specifically Hot Chocolate (Cioco Delice White Chocolate), Decaf Coffee, and Vinegar from Caffe Molinari S.P.A., Italy. A Form FDA 483a FSVP Observations was issued on May 20, 2022. Despite the firm's stated intention to consult a third-party specialist and a follow-up email from the Division of Southwest Imports (DSWI) Compliance Branch on June 6, 2022, no response or corrective action status was received.

Failure to address this violation may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-