FDA WARNING_LETTER - Coastal Fresh Farms, Inc. - February 09, 2022

On January 31 through February 9, 2022, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Coastal Fresh Farms, Inc., following a previous inspection in August 2020. The inspection aimed to determine compliance with section 805 of the FD&C Act and the implementing FSVP regulation in 21 CFR part 1, subpart L. The FDA found significant violations, as the firm failed to develop, maintain, and follow an FSVP for any foods imported into the U.S., as required by 21 CFR 1.502(a). During the August 2020 inspection, provided documents like a "FSMA-VENDOR APPROVAL" SOP and audit reports were incomplete and did not constitute a compliant FSVP. No FSVP documents were provided during the most recent inspection. The firm imports raw agricultural commodity produce, which requires the FSVP to demonstrate supplier compliance with 21 CFR part 112. Coastal Fresh Farms, Inc. must respond in writing within fifteen working days, detailing specific corrective actions and providing documentation of a compliant FSVP. Failure to adequately address these violations may result in refusal of admission for imported foods under section 801(a)(3) of the FD&C Act and detention without physical examination, and is prohibited under section 301(zz).