FDA WARNING_LETTER - Fresh International, LLC - February 02, 2022

On May 4, 2022, the FDA issued a Warning Letter to Fresh Imports International LLC following Foreign Supplier Verification Program (FSVP) inspections on January 31-February 2, 2022, and August 18, 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 ensure imported food meets U.S. safety standards.

The primary violation identified was the firm's failure to develop, maintain, and follow an FSVP for imported foods, including fresh avocados and pineapples from various suppliers. This was a repeat violation, as the firm also lacked FSVP records during the 2020 inspection. Although the firm responded on February 2, 2022, acknowledging non-compliance and stating a plan to follow FDA guidelines and take an FSVP class, no documentation of corrective actions was provided.

The FDA emphasized that this significant violation of the FSVP regulation also constitutes non-compliance with Section 805 of the FD&C Act. The letter noted that since the firm imports "covered produce" (fresh produce), its FSVP must demonstrate supplier compliance with the Produce Safety Rule (21 CFR Part 112).

Failure to adequately address these issues may result in further action, including refusal of admission of imported food under