FDA WARNING_LETTER - Garden Fresh Market - March 30, 2021

On March 22-30, 2021, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Garden Fresh Market, following a previous inspection on July 25, 2019. 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 FDA found that Garden Fresh Market was not in compliance, specifically lacking FSVPs for pickled tomatoes, pickled tomatoes and cucumbers, and half sour pickles imported from (b)(4). This constitutes a significant violation of Section 805 of the FD&C Act and 21 CFR 1.502(a).

Despite receiving Form FDA 483a, FSVP Observations, after both inspections, and submitting responses on September 10, 2019, and April 16, 2021, the firm continued to import food without developing the required FSVPs. Previous assurances of not importing or using local distributors were not followed by corrective actions.

The FDA requires a written response within fifteen working days detailing corrective actions, including documentation like a copy of the developed FSVP and records of its implementation. Failure to address these violations may result in refusal of admission for imported products under Section 801(a)(3