FDA WARNING_LETTER - PREMIUM FRESH GROWERS LLC - November 25, 2024

On December 18, 2024, the FDA issued a Warning Letter to Premium Fresh Growers LLC following a Foreign Supplier Verification Program (FSVP) inspection from October 24 to November 25, 2024, and a prior inspection from May 25 to July 27, 2023. 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 that imported food meets U.S. food safety standards.

The FDA found that Premium Fresh Growers LLC is not in compliance with these requirements, specifically failing to develop, maintain, and follow an FSVP for any imported foods, including fresh produce. If the imported fresh produce is "covered produce" as defined in 21 CFR 112.3, the FSVP must demonstrate compliance with produce safety standards under Section 419 of the FD&C Act and 21 CFR Part 112.

The company received a Form FDA 483a FSVP Observations on November 25, 2024, but has not submitted a response. These violations signify non-compliance with Section 805 of the FD&C Act. Failure to adequately address these issues may lead to further FDA action, including refusal of admission for imported food under Section 801(