FDA WARNING_LETTER - Greenfield Produce Imports - January 27, 2022

On May 10, 2022, the FDA issued a Warning Letter to Greenfield Produce Imports following Foreign Supplier Verification Program (FSVP) inspections conducted from January 25-27, 2022, and previously on March 27, 2020. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L.

The FDA found significant violations, specifically that Greenfield Produce Imports failed to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). Although the company provided some foreign supplier documents (audit reports not in English, HACCP, and food safety certificates), these were deemed incomplete and lacked evidence of review or application to an FSVP program. A Form FDA 483a FSVP Observations was issued on January 27, 2022, to which no response was received.

Failure to address these violations 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 #99-41, and prohibition of importation under Section 301(zz). The FDA also noted that imported fresh produce, being "covered produce," requires the FSVP to demonstrate supplier compliance with 21