FDA WARNING_LETTER - Triple J Fresh, LLC - January 07, 2022

On January 6 and 7, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Triple J Fresh, LLC, following a previous inspection on May 5, 2020. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandate risk-based activities for importers to verify imported food meets U.S. safety standards.

The FDA found Triple J Fresh, LLC not in compliance with FSVP requirements, specifically failing to develop, maintain, and follow an FSVP for imported foods including fresh broccoli, fresh coriander, and fresh Persian limes. This violates Section 805 of the FD&C Act and 21 CFR 1.502(a). A Form FDA 483a FSVP Observations was issued on January 7, 2022, to which no response was received.

Failure to address these violations may lead to 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 #99-41, and prohibition of importation under Section 301(zz) of the FD&C Act. Triple J Fresh, LLC must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation, or explaining any delays